AccessGUDID - DEVICE: neoBLUE (00382830053686)

GUDID

Device Identifier (DI) Information

Brand Name: neoBLUE
Version or Model: blanket Light Box
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 024738, 024915
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830053686
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962519208 *Terms of Use

Device Description: neoBLUE blanket Light Box

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
33791	Blanket/pad infant phototherapy unit	A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a light source that connects to a blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. It is intended for use in the home and a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBI	Unit, Neonatal Phototherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 57 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Temperature: between -30 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d9dd4a9-041f-460b-b6a2-ba17468a6d56
Public Version Date: February 16, 2024
Public Version Number: 3
DI Record Publish Date: December 17, 2018