GUDID 00721902046940

SFTWR 9767 HEAD PRGMG RF TLMY SYS A/B

MEDTRONIC, INC.

Cardiac output unit application software Cardiac output unit application software Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer Cardiac pulse generator programmer
Primary Device ID00721902046940
NIH Device Record Key855ef68e-7652-4f87-bfe5-2374e2edc66a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9767
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902046940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000894689 - SHERPA NX BALANCED™2024-06-07 CATHETER SB6MP1K SB 6F 55CM MP1
00763000894726 - SHERPA NX BALANCED™2024-06-07 CATHETER SB6MPHK SB 55CM MPH
00763000894801 - SHERPA NX BALANCED™2024-06-07 CATHETER SB6PK1W SB 6F 47CM PK1
00763000894917 - SHERPA NX BALANCED™2024-06-07 CATHETER SB6RDCK SB 6F 55CM RDC
00763000895754 - SHERPA NX BALANCED™2024-06-07 CATHETER SB7IMAK SB 7F 55CM IMA
00763000901905 - Launcher™2024-06-07 CATHETER LA8NOTOSH LA 8F 100CM NOTO
00763000902230 - Launcher™2024-06-07 CATHETER LA8SCR35SH LA 8F 100CM SCR35
00763000902520 - Launcher™2024-06-07 CATHETER LA83DRC LA 8F 100CM 3DRC
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.