Home GUDID 30884838096579 BiliChek
Primary DI 30884838096579
Brand BiliChek
Company Philips Medical Systems Hsg
Model Bilical, 50 Pack
Catalog number B800-50
Device description Bilical, 50 Pack
Published 2022-10-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MQM Bilirubin (Total And Unbound) In The Neonate Test System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884838096578 Primary GS1 0 30884838096579 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00884838096578 00884838096578 884838096578 0884838096578 30884838096579 30884838096579
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 0 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature 0 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 32 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 790605856 Device count 50 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00884838048089 Philips 12-Lead Patient Cable (AAMI), Std Length 989803184931 2023-05-25 00884838048102 Philips 12-Lead Patient Cable (AAMI), Long 989803184951 2023-05-25 00884838012974 NOUN PW CBL Complete Lead Set AAMI 989803151631 2016-12-06 00884838012981 NOUN PW CBL Complete Lead Set IEC 989803151641 2016-12-06 00884838012998 NOUN Chest Lead Set, AAMI/IEC 989803151671 2016-12-06 00884838013001 NOUN Long Chest Lead Set (Both AAMI and IEC) 989803151691 2016-11-11 00884838013025 NOUN Limb Lead Set (Both AAMI and IEC) 989803151711 2016-11-03 00884838013032 NOUN Long Limb Lead Set (Both AAMI and IEC) 989803151731 2017-06-07 00884838013049 NOUN TC ADDITIONAL LEADS KIT: AAMI 989803151751 2017-05-11 00884838013056 NOUN TC ADDITIONAL LEADS KIT: IEC 989803151761 2017-04-12 00884838014978 NOUN Long Complete Lead Set AAMI 989803151651 2017-01-26 00884838014985 NOUN PW CBL Long Complete Lead Set IEC 989803151661 2017-01-04 00884838014992 NOUN TC ADDITIONAL LONG LEADS KIT: AAMI 989803151771 2017-11-08 00884838015005 NOUN TC ADDITIONAL LONG LEADS KIT: IEC 989803151781 2017-04-28 00884838025479 NOUN PW TC20 10-Lead Patient Cable IEC 989803175891 2016-10-06 00884838025486 NOUN PW TC20 10-Lead Patient Cable AHA 989803175901 2016-11-23 00884838025493 NOUN PW TC20 Long 10-Lead Patient Cable IEC 989803175911 2016-11-03 00884838025509 NOUN PW TC20 Long 10-Lead Patient Cable AHA 989803175921 2016-10-06 00884838029118 NOUN 12L Leadset, Grabber, AAMI 989803180121 2016-12-19 00884838029125 NOUN 12L Leadset, Grabber, IEC 989803180131 2016-11-24
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