- Physicians Office Resource

BilEclipse Phototherapy Protective Patch is a single use accessory of BiliChek Non
BiliChek - BILECLIPSE, 50 PACK

Device Description

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.

Environmental Conditions

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
0.00

Storage Environment Temperature - Degrees Celsius

30.00
0.00

Storage Environment Temperature - Degrees Fahrenheit

86.00
32.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KGX

Device Name: Tape And Bandage, Adhesive

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5240

Third Party Flag: N

Medical Specialty: HO

Device Identifiers

Device Id: 00884838051751

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 30884838051752

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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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.