AccessGUDID - DEVICE: MiniMed Reservoir (00643169771437)

GUDID

Device Identifier (DI) Information

Brand Name: MiniMed Reservoir
Version or Model: MMT-326A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC MINIMED, INC.

Primary DI Number: 00643169771437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 849626338 *Terms of Use

Device Description: RSVR MMT-326A 10PK PDGM 1.8ML 21L 3YR

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
35838	Ambulatory insulin infusion pump reservoir	An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZP	Automated insulin dosing device system, single hormonal control
FRN	Pump, infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001828	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69a66c4c-abf6-44fd-8a54-fe3ee772abbe
Public Version Date: August 13, 2018
Public Version Number: 1
DI Record Publish Date: July 12, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40643169771435	72	00643169771437		In Commercial Distribution	CT

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 70643169771436 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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES