AccessGUDID - DEVICE: Momcozy (06975983272031)

GUDID

Device Identifier (DI) Information

Brand Name: Momcozy
Version or Model: BF009_6PC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Shenzhen Lutejiacheng Supply Chain Management Co., Ltd.

Primary DI Number: 06975983272031
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 615691114 *Terms of Use

Device Description: hydrogel breast Pads

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):	No
Over the Counter (OTC):	Yes
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?
10484	Nipple pad/ring, single-use	A device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. It may be in the form of a fabric or cotton pad (commonly known as a nursing pad), a dome-shaped gel (e.g., hydrogel) cover, or a ring. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTC	Nursing Pad, Hydrogel

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: cd6bc5f0-9ff5-42f2-bb05-3ba3ba8d6057
Public Version Date: November 16, 2023
Public Version Number: 1
DI Record Publish Date: November 08, 2023