AccessGUDID - DEVICE: Swaddler for Phototherapy (00859911004276)

GUDID

Device Identifier (DI) Information

Brand Name: Swaddler for Phototherapy
Version or Model: 1100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1100
Company Name: Bionix, LLC

Primary DI Number: 00859911004276
Issuing Agency: GS1
Commercial Distribution End Date: April 10, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 117844489 *Terms of Use

Device Description: Swaddler for PhotoTherapy: Preemie

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:	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?
64254	Phototherapy infant blanket	A piece of fabric, made of an ultraviolet (UV) light-transmittable material, intended to be used to wrap a newborn/infant during UV phototherapy for the treatment of neonatal jaundice (neonatal hyperbilirubinemia) to enable therapeutic light to pass through to the patient while simultaneously providing comfort. It does not include a light source. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDH	blanket, neonatal phototherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123411	000

Device Exempt from Premarket Submission: No 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: 9e39be77-e760-4a35-a5be-50d09f24313d
Public Version Date: April 11, 2024
Public Version Number: 7
DI Record Publish Date: February 01, 2017