AccessGUDID - DEVICE: Preemie Transport Blanket (00714646000491)

GUDID

Device Identifier (DI) Information

Brand Name: Preemie Transport Blanket
Version or Model: 1125
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1125
Company Name: Bionix, LLC

Primary DI Number: 00714646000491
Issuing Agency: GS1
Commercial Distribution End Date: August 23, 2025
Device Count: 15
Labeler D-U-N-S® Number*: 117844489 *Terms of Use

Device Description: Preemie Transport Blanket, Low Birth Weight Blankets - 15ct

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):	Yes
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?
58934	Infant blanket, single-use	A piece of fabric material intended to be used to wrap newborns/infants to retain their body heat and/or absorb fluids. Commonly known as a baby blanket, it is available in a variety of fabrics (e.g., wool, cotton, or synthetic materials) and textures (e.g., cellular or smooth). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	BEDDING, DISPOSABLE, MEDICAL

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: dc4ee740-bdde-4609-af79-1afd9114857c
Public Version Date: August 25, 2025
Public Version Number: 2
DI Record Publish Date: July 19, 2023