Guardian™ Link (3)

GUDID 00763000372002

REPLACEMENT MMT-7911NA ASSY GST5C US

MEDTRONIC MINIMED, INC.

Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system
Primary Device ID00763000372002
NIH Device Record Key9a71b865-ff3c-466e-b1e6-6727d72c4302
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuardian™ Link (3)
Version Model NumberMMT-7911NA
Company DUNS849626338
Company NameMEDTRONIC MINIMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000372002 [Primary]
GS100763000372002 [Primary]
GS100763000372002 [Primary]
GS100763000372002 [Primary]
GS100763000372002 [Primary]
GS100763000372002 [Primary]
GS100763000372002 [Primary]
GS100763000372002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZPAutomated insulin dosing device system, single hormonal control
OZPAutomated insulin dosing device system, single hormonal control
OZPAutomated insulin dosing device system, single hormonal control
OZPAutomated insulin dosing device system, single hormonal control
OZPAutomated insulin dosing device system, single hormonal control
OZPAutomated insulin dosing device system, single hormonal control
OZPAutomated insulin dosing device system, single hormonal control
OZPAutomated insulin dosing device system, single hormonal control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Guardian™ Link (3)]

00643169955691XMTR MMT-7811NA GST3C LOCKOUT US
00763000215538RPL MMT-7811NA GST3C LOCKOUT 2.2A ARM
00763000166540RPL MMT-7811NA GST3C LOCKOUT 2.1C ARM
00763000146849XMTR MMT-7811NA GST3C LOCKOUT V2.1C
00763000286781KIT MMT-7810PNA XMTR GST3C 2.2A RX
00763000286774KIT MMT-7810PN1 XMTR GST3C 2.1C RX
00763000239831RPL MMT-7811N1 GST3C LOCKOUT 2.1C ARM
00763000239824STRT KIT MMT-7810N1 XMTR GST3C 2.1C ARM
00763000400620RPL MMT-7811NA GST3C LOCKOUT 2.2A ARM CD
00763000386986STRT KIT MMT-7810PNA GST3C 2.2A RX CD
00763000316990STARTER KIT MMT-7910NA ASSY GST5C US
00763000391065KIT ASSY PKG MMT-7811NA INTRICON
00763000391034KIT ASSY PKG MMT-7810PNA INTRICON US
00763000372002REPLACEMENT MMT-7911NA ASSY GST5C US

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.