AccessGUDID - DEVICE: Guardian ™ Sensor (3) (20643169704057)

GUDID

Device Identifier (DI) Information

Brand Name: Guardian ™ Sensor (3)
Version or Model: MMT-7020A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC MINIMED, INC.

Primary DI Number: 20643169704057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 849626338 *Terms of Use

Device Description: SENSOR MMT-7020A ENLITE3 5PK 2L US

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59016	Percutaneous interstitial-fluid glucose monitoring system sensor	A small, electronic device with micro-needle(s) intended to be inserted percutaneously into interstitial tissue to continuously measure and record interstitial-fluid glucose concentrations, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is typically a thin, flexible, needle electrode that uses electrochemical means to convert glucose levels into an electrical signal. It typically has an adhesive covering that holds it to the skin surface, and transmits the signal via a cable or transmitter. This is a single-patient device intended be used for a period before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZP	Artificial pancreas device system, single hormonal control
MDS	Sensor, glucose, invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160017	003

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8efa9659-6f74-4c7b-9be4-defc8da990dc
Public Version Date: May 22, 2025
Public Version Number: 8
DI Record Publish Date: April 03, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00643169704053 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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