AccessGUDID - DEVICE: mamivac® Nipple Shields S, cherry shaped (14250373654932)

GUDID

Device Identifier (DI) Information

Brand Name: mamivac® Nipple Shields S, cherry shaped
Version or Model: Size S, cherry shaped
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 281481
Company Name: Kimetec GmbH

Primary DI Number: 14250373654932
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 325911063 *Terms of Use

Device Description: Nipple Shields, cherry shaped, size S

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):	No
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?
35337	Nipple shielding teat, reusable	A device in the form of a flexible dome with milk-flow holes designed to be worn on a nipple by a nursing mother to facilitate breast feeding when an infant has latch-on problems (i.e., aberrant suckling technique), is premature, ill, or small (suction inside the device holds the nipple in an extended position), or when the mother has flat or inverted nipples (it provides sensation deep in the mouth that stimulates the baby). It is typically made of preformed silicone materials that additionally provide nipple protection. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFS	Shield, Nipple

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51e75530-1154-4a78-a1ca-5a9c40f4f17c
Public Version Date: July 11, 2023
Public Version Number: 1
DI Record Publish Date: July 03, 2023