GUDID 00721902710322

ANALYZER R2290 PATIENT GLOBAL MODEL 2290

MEDTRONIC, INC.

Implantable pacemaker analyser, intraoperative
Primary Device ID00721902710322
NIH Device Record Key88e0405f-e00c-4c4b-9eb8-38d8555be2b3
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR2290
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

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902710322 [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.

00199150029815 - NA2025-07-18 CUSTOM PACK BB9J91R11 CP PRIME
00199150029839 - NA2025-07-18 CUSTOM PACK BB12B96R7 1/4 SPECTRUM
00199150031603 - NA2025-07-18 CUSTOM PACK BB2R88R9 PUMP/TABL
00199150032457 - NA2025-07-18 CUSTOM PACK BB8L48R9 TABLE PK
00199150033430 - NA2025-07-18 CUSTOM PACK BB12E24R9 UNC GOLD PD
00199150033461 - NA2025-07-18 CUSTOM PACK BB12Q81R H/L 1/2 IN TU
00199150033546 - NA2025-07-18 CUSTOM PACK BB5N65R17 OSU E
00199150033553 - NA2025-07-18 CUSTOM PACK BB12Q62R NORTON HEALTH

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.