GUDID 00763000180904

ACTV PA97000 USA

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00763000180904
NIH Device Record Keye06ce4cc-b61b-4d0f-83a5-022cee5406f7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPA97000
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000180904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-29
Device Publish Date2020-06-21

Devices Manufactured by MEDTRONIC, INC.

00763000517809 - Hancock™2025-05-22 CONDUIT HC150-16 HK1 MO 26L
00763000517816 - Hancock™2025-05-22 CONDUIT HC150-18 HK1 MO 26L
00763000517823 - Hancock™2025-05-22 CONDUIT HC150-20 HK1 MO 26L
00763000517847 - Hancock™2025-05-22 CONDUIT HC150-25 HK1 MO 26L
00763000612382 - CG Future™2025-05-20 BAND 638BL26 CG FUTURE ANULO 33L MDR
00763000612399 - CG Future™2025-05-20 BAND 638BL28 CG FUTURE ANULO 33L MDR
00763000612405 - CG Future™2025-05-20 BAND 638BL30 CG FUTURE ANULO 33L MDR
00763000612412 - CG Future™2025-05-20 BAND 638BL32 CG FUTURE ANULO 33L MDR

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