AccessGUDID - DEVICE: Fun Ice Chewy Teether (00735282740015)

GUDID

Device Identifier (DI) Information

Brand Name: Fun Ice Chewy Teether
Version or Model: 74001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MUNCHKIN, INC.

Primary DI Number: 00735282740015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 787026855 *Terms of Use

Device Description: Cool gel that soothes gums Ridges to massage sore gums Easy-to-grasp hand/ foot shape

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?
44272	Teething device, fluid-filled	A circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KKO	Ring, Teething, Fluid-Filled

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: 2fbf3151-42cb-4621-a92f-da4932ffa373
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 12, 2019