GUDID 00643169782730

MONITOR 24965 USA MKT EIFU

MEDTRONIC, INC.

Cardiac pulse generator reader, professional
Primary Device ID00643169782730
NIH Device Record Keye9f6dba5-2d14-4528-8981-bae4a2212399
Commercial Distribution StatusIn Commercial Distribution
Version Model Number24965
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

Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169782730 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-04

Devices Manufactured by MEDTRONIC, INC.

00763000893910 - SHERPA NX BALANCED™2024-12-20 CATHETER SB6FL40SH SB 6F 100CM FL40
00763000893941 - SHERPA NX BALANCED™2024-12-20 CATHETER SB6FR40SH SB 6F 100CM FR40
00763000988258 - NA2024-12-20 CUSTOM PACK BB10Q85R1 FILTER
00763000988760 - NA2024-12-20 CUSTOM PACK BB1F66R26 CASPER
00763000973391 - Sphere-9™ Catheter2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR
00763000986704 - NA2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC
00763000986773 - NA2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK
20763000986814 - NA2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.