AccessGUDID - DEVICE: Kidgets Doll Teether (00032251045806)

GUDID

Device Identifier (DI) Information

Brand Name: Kidgets Doll Teether
Version or Model: SKU 1600132
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Regent Baby Products Corp.

Primary DI Number: 00032251045806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005910997 *Terms of Use

Device Description: Doll Teether~The Doll Teether is a multi-textured toy and provides your child different surfaces to feel and touch. It also enhances your baby's sense of security and comfort. Distributed by MidwoodBrands LLC 10611 Monroe Road, Matthews, North Carolina 28105 USA. MidwoodBrands LLC 0322510458060617

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
KYX	Dispenser, Liquid Medication

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: aa020f69-e4f4-47d0-b0b6-b9055fba167b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 08, 2017