AccessGUDID - DEVICE: Bili-Bonnet (00815090010002)

GUDID

Device Identifier (DI) Information

Brand Name: Bili-Bonnet
Version or Model: 01A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01A
Company Name: SMALL BEGINNINGS INC

Primary DI Number: 00815090010002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002657679 *Terms of Use

Device Description: Bili-Bonnet Preemie size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice.

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?
11661	Eye pad	A cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOK	Pad, Neonatal Eye

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
Device Size Text, specify: Preemie

Device Record Status

Public Device Record Key: 47344a30-c266-4208-8586-48d0c82b6a0d
Public Version Date: August 11, 2020
Public Version Number: 1
DI Record Publish Date: August 03, 2020