AccessGUDID - DEVICE: BiliChek (30884838051752)

GUDID

Device Identifier (DI) Information

Brand Name: BiliChek
Version or Model: BILECLIPSE, 50 PACK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B800-11
Company Name: Philips Medical Systems Hsg

Primary DI Number: 30884838051752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: BilEclipse Phototherapy Protective Patch is a single use accessory of BiliChek Non-Invasive Bilirubin Analyzer intended for use as a target window when non-invasive transcutaneous measurement of neonatal bilirubin levels is required. The device is intended to interact with patient intact skin only.

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?
16166	Transcutaneous bilirubinometer	A noninvasive, battery-powered, hand-held, portable instrument intended to measure transcutaneous bilirubin (TcB) levels, in order to predict total serum bilirubin (TSB) levels in a neonate. It directs a light beam into the newborn’s skin, usually on the forehead, sternum or ear, and measures the intensity of multiple wavelengths (typically 2 or more) that are reflected from the newborns subcutaneous tissue. These optical signals are processed (typically by a photocell and microprocessor) to give a TcB and/or TSB value. It is used mainly for screening hyperbilirubinemia.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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
Storage Environment Temperature: between 0 and 30 Degrees Celsius
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3b946232-673d-44bd-ac75-d46a71ba4baa
Public Version Date: April 02, 2024
Public Version Number: 3
DI Record Publish Date: October 21, 2022