CUSTOM PACK 7J07R1 5PK L TXP A Medical Device Identification

GUDID 20643169993086

CUSTOM PACK 7J07R1 5PK L TXP A

MEDTRONIC, INC.

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Primary Device ID	20643169993086
NIH Device Record Key	2a9c2e47-806c-4c14-91a2-6ab8ff0bb53f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	7J07R1
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169993075 [Primary]
GS1	20643169993086 [Package] Contains: 00643169993075 Package: PK [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K800178

FDA Product Code

DWE	TUBING, PUMP, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-04-27

Devices Manufactured by MEDTRONIC, INC.

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00763000953614 - NA	2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN
00763000953621 - NA	2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC
00763000953638 - NA	2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
00763000953645 - NA	2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP
20763000953663 - NA	2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA	2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK