GUDID 00613994524232

CABLE 2090EC CARELNK ECG 6FT W/PLUG

MEDTRONIC, INC.

Electrical-only medical device connection cable, reusable
Primary Device ID00613994524232
NIH Device Record Key65c64223-e360-442e-96ea-4211f50946cc
Commercial Distribution Discontinuation2019-01-25
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number2090EC
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exempttrue
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

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994524232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994524232]

Ethylene Oxide


[00613994524232]

Ethylene Oxide


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.

00613994163516 - Annuloplasty Handle2025-12-30 TOOL 7615XL HANDLE ANLO 14L
00613994838087 - Contour 3D™2025-12-30 TOOL 7690S CNTOUR 3D SZRSET REUSABLE 26L
00613994862488 - Annuloplasty Handle2025-12-30 TOOL 7686 ANNULOPLASTY HANDLE 216 MM 26L
00613994867988 - Medtronic Open Pivot™2025-12-30 ACCY 576 MHV SIZER SET
00643169525603 - Duran AnCore™2025-12-30 SIZER SET 7620S DURAN ANCORE 26L
00643169525610 - Annuloplasty Handle2025-12-30 HANDLE 7615 ANNULOPLASTY 26L
00643169525634 - Annuloplasty Handle2025-12-30 HANDLE 7686 ANNULOPLASTY 26L
00643169525641 - Annuloplasty Handle2025-12-30 HANDLE 7686XL ANNULOPLASTY 26L

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