GUDID 00721902290121

CABLE 2067 RF HEAD 9FT GLOBAL MR

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use Cardiac pulse generator reader, home-use
Primary Device ID00721902290121
NIH Device Record Key9af9f393-4efc-40ad-a4f6-b557ee0bdf8b
Commercial Distribution Discontinuation2018-07-26
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number2067
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

Device Dimensions

Length9 Feet
Length9 Feet

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
GS100721902290121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRGProgrammer, pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-30
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000944322 - NA2024-04-23 CUSTOM PACK HY4953R31 MEMB PK
00763000944339 - NA2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK
00763000944346 - NA2024-04-23 CUSTOM PACK BB12F35R5 A PACK
00763000945558 - NA2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO
00763000943844 - NA2024-04-12 CUSTOM PACK BB11J59R5 PEDS
00763000943851 - NA2024-04-12 CUSTOM PACK BB12F35R3 A PACK
00763000943868 - NA2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
00763000943899 - NA2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD

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