GUDID 00613994520296

LINE ASSY BTC96 SUCTIANTICOAG W/STPDWN

MEDTRONIC, INC.

Blood-processing autotransfusion system set Blood-processing autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set
Primary Device ID00613994520296
NIH Device Record Key0de5c6ab-8113-4695-930f-67b628173eae
Commercial Distribution Discontinuation2015-06-16
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberBTC96
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994520296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACAPPARATUS, AUTOTRANSFUSION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-09

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00763000902568 - Launcher™2024-06-04 CATHETER LA83DRIGHT LA 8F 100CM 3DRGT
00763000902575 - Launcher™2024-06-04 CATHETER LA83DRIGHTD LA 8F 90CM 3DRGT
00763000902582 - Launcher™2024-06-04 CATHETER LA8AL10 LA 8F 100CM AL10
00763000902599 - Launcher™2024-06-04 CATHETER LA8AL10D LA 8F 90CM AL10
00763000902605 - Launcher™2024-06-04 CATHETER LA8AL10F LA 8F 80CM AL10
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