Guardian™ Sensor (3)

GUDID 00763000358440

SENSOR MMT-7020PLA GS3 5PK 2L US

MEDTRONIC MINIMED, INC.

Percutaneous interstitial-fluid glucose monitoring system sensor Percutaneous interstitial-fluid glucose monitoring system sensor Percutaneous interstitial-fluid glucose monitoring system sensor Percutaneous interstitial-fluid glucose monitoring system sensor Percutaneous interstitial-fluid glucose monitoring system sensor Percutaneous interstitial-fluid glucose monitoring system sensor Percutaneous interstitial-fluid glucose monitoring system sensor Percutaneous interstitial-fluid glucose monitoring system sensor
Primary Device ID00763000358440
NIH Device Record Key5f0faea6-e9a8-4445-bcc4-ed2ec247bd66
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuardian™ Sensor (3)
Version Model NumberMMT-7020PLA
Company DUNS849626338
Company NameMEDTRONIC MINIMED, INC.
Device Count5
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
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 TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000358440 [Unit of Use]
GS100763000358440 [Unit of Use]
GS100763000358440 [Unit of Use]
GS100763000358440 [Unit of Use]
GS100763000358440 [Unit of Use]
GS100763000358440 [Unit of Use]
GS100763000358440 [Unit of Use]
GS100763000358440 [Unit of Use]
GS120763000358444 [Primary]
GS120763000358444 [Primary]
GS120763000358444 [Primary]
GS120763000358444 [Primary]
GS120763000358444 [Primary]
GS120763000358444 [Primary]
GS120763000358444 [Primary]
GS120763000358444 [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 Date2020-10-31

On-Brand Devices [Guardian™ Sensor (3)]

00763000157616SENSOR MMT-7020B GS3 1PK 2L US
00763000140779SENSOR MMT-7020B GS3 1PK 2L US
20763000157603SENSOR MMT-7020A GS3 5PK 2L US
20763000140940SENSOR MMT-7020A GS3 5PK 2L US
20763000179629SENSOR MMT-7020GA GS3 5PK US GC
00763000179601SENSOR MMT-7020GA GS3 5PK US GC
00763000337001SENSOR MMT-7020A GS3 5PK 2L US
00763000337049SENSOR MMT-7020B GS3 1PK 2L US
00763000336998SENSOR MMT-7020LB GS3 1PK US
00763000336981SENSOR MMT-7020LA GS3 5PK US
00763000358440SENSOR MMT-7020PLA GS3 5PK 2L US

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