AccessGUDID - DEVICE: Momcozy (06975983272048)

GUDID

Device Identifier (DI) Information

Brand Name: Momcozy
Version or Model: MCBOC01_40PC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Shenzhen Lutejiacheng Supply Chain Management Co., Ltd.

Primary DI Number: 06975983272048
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 615691114 *Terms of Use

Device Description: Baby Oral Cleaner

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?
48037	Oral care swab	A device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare settings. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXF	Applicator, Absorbent Tipped, Non-Sterile

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: f6b78f52-8411-44a2-b8bb-e416d77884a4
Public Version Date: November 20, 2023
Public Version Number: 1
DI Record Publish Date: November 10, 2023