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 20884838015245 HeartStart External Paddles Water Resistant M3543A 2014-09-24 00884838090088 MX40 Masimo Leadsets and Adapters MX40 Adapter 5-Lead + Masimo SpO2 989803202381 2022-05-23 00884838090095 MX40 Masimo Leadsets and Adapters MX40 Adapter Masimo SpO2-only 989803202391 2022-05-23 00884838090101 MX40 Masimo Leadsets and Adapters ECG 5L Grabber, AAMI, Masimo SpO2 , Tele 989803202411 2020-04-21 00884838090118 MX40 Masimo Leadsets and Adapters ECG 5L Grabber, IEC, Masimo SpO2 , Tele 989803202421 2020-04-21 00884838091276 MX40 Masimo Leadsets and Adapters MX40 Adapter 6-Lead + Masimo SpO2 989803204291 2020-04-21 00884838013360 ECG Electrodes CBL ECG 3LEAD GRABBER, AAMI + SPO2, TELE 989803171811 2017-07-13 00884838013377 ECG Electrodes CBL ECG 5 LEAD SNAPS, AAMI, TELE 989803171821 2016-10-13 00884838013384 ECG Electrodes CBL ECG 5 LEAD GRABBER, AAMI, TELE 989803171831 2016-09-27 00884838013391 ECG Electrodes CBL ECG 5 LEAD SNAPS, AAMI + SPO2, TELE 989803171841 2016-09-27 00884838013407 ECG Electrodes CBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE 989803171851 2016-09-27 00884838013414 ECG Electrodes CBL ECG 6 LEAD GRABBER, AAMI, TELE 989803171861 2017-07-27 20884838013517 ECG Electrodes CBL ECG 5 LEAD GRABBER IEC, SPU, TELE 989803172131 2020-03-25 20884838013494 ECG Electrodes CBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE 989803172031 2016-10-12 00884838013421 ECG Electrodes CBL ECG 6LEAD GRABBER, AAMI + SPO2, TELE 989803171871 2016-11-22 00884838013445 ECG Electrodes CBL ECG 3 LEAD GRABBER, IEC + SPO2, TELE 989803171911 2016-11-29 00884838013452 ECG Electrodes CBL ECG 5 LEAD GRABBER, IEC, TELE 989803171931 2016-10-13 00884838013469 ECG Electrodes CBL ECG 5 LEAD GRABBER, IEC + SPO2, TELE 989803171951 2016-10-13 00884838013476 ECG Electrodes CBL ECG 6 LEAD GRABBER, IEC, TELE 989803171961 2016-11-01 00884838013483 ECG Electrodes CBL ECG 6 LEAD GRABBER, IEC+SPO2, TELE 989803171971 2016-12-07
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