GUDID 00613994521750

CABLE 2292 ANALYZER OUS MKT

MEDTRONIC, INC.

Electrical-only medical device connection cable, reusable
Primary Device ID00613994521750
NIH Device Record Keyd6be1e20-ba98-49c4-a511-dc14956dd881
Commercial Distribution Discontinuation2019-01-25
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number2292
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 Batchtrue
Serial Numberfalse
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 HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994521750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FQMBANDAGE, ELASTIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994521750]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00613994521750]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-13
Device Publish Date2014-09-23

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.