CGMS® iPro™

Primary DI
00613994343604
Brand
CGMS® iPro™
Company
MEDTRONIC MINIMED, INC.
Model
MMT-7708NA
Device description
SYSTEM MMT-7708NA CGMS IPRO V1.0 EN
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
MDSSensor, glucose, invasive
OYCPump, infusion, insulin, to be used with invasive glucose sensor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
MDSSensor, Glucose, InvasiveUnknown3
OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose SensorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980022020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980022020CONTINUOUS GLUCOSE MONITORING SYSTEMMedtronic Minimed1999-06-15MDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994343604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994343604006139943436046139943436040613994343604

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous interstitial fluid glucose monitoring system, electrochemicalAn assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
849626338
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20763000565026Simplera™ SensorMMT-5100JA2025-03-17
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20763000829654Simplera™ SensorMMT-5101PN2025-03-17
20763000956381Simplera Sync™MMT-5120A2025-06-01
70643169771481MiniMed™ ReservoirMMT-332A2018-05-31
00643169705920Sil-serter™MMT-3852022-09-17
00643169771413MiniMed ReservoirMMT-326A2016-10-03

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