AccessGUDID - DEVICE: One-press Serter (00763000859206)

GUDID

Device Identifier (DI) Information

Brand Name: One-press Serter
Version or Model: MMT-7512G
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC MINIMED, INC.

Primary DI Number: 00763000859206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 849626338 *Terms of Use

Device Description: SERTER MMT-7512G IIN 1CLK G4S US 3L

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:	No
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?
45449	Injector reset device	A device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160017	091

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d689141b-75ef-435e-8338-209dade306bc
Public Version Date: September 04, 2023
Public Version Number: 1
DI Record Publish Date: August 27, 2023

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: No Unit of Use DI Numbers Found 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