AccessGUDID - DEVICE: NFLOW INFANT BONNET, DARK GREY, SIZE 1 (05030267088454)

GUDID

Device Identifier (DI) Information

Brand Name: NFLOW INFANT BONNET, DARK GREY, SIZE 1
Version or Model: 4707001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intersurgical Incorporated

Primary DI Number: 05030267088454
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785952607 *Terms of Use

Device Description: NFLOW INFANT BONNET, DARK GREY, SIZE 1

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
17142	Infant head cap	A small covering designed as a cap intended to be worn by a patient in infancy (an infant). It is primarily used to prevent loss of heat from the head and is typically made of fabric materials, e.g., cotton. This is a reusable garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAY	Support, Breathing Tube

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: 7bbbada2-d689-4c2d-852a-c2cf66777664
Public Version Date: February 11, 2025
Public Version Number: 3
DI Record Publish Date: October 25, 2021