FDA.reportPublic FDA data

BiliChek

Primary DI
00884838096578
Brand
BiliChek
Company
Philips Medical Systems Hsg
Model
Bilical, 50 Pack
Catalog number
B800-50
Device description
BiliCal BiliChek Disposable Calibration Tip is a single use accessory of BiliChek Non-Invasive Bilirubin Analyzer intended to calibrate the filtered light of the BiliChek Non-Invasive Bilirubin Analyzer when non-invasive transcutaneous measurement of neonatal bilirubin levels is required. The device is intended to interact with patient intact skin only.
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQMBilirubin (Total And Unbound) In The Neonate Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQMBilirubin (Total And Unbound) In The Neonate Test SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838096578PrimaryGS10
30884838096579Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838096578008848380965788848380965780884838096578
3088483809657930884838096579

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous bilirubinometerA 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
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
790605856
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12
00884838014978NOUNLong Complete Lead Set AAMI9898031516512017-01-26
00884838014985NOUNPW CBL Long Complete Lead Set IEC9898031516612017-01-04
00884838014992NOUNTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712017-11-08
00884838015005NOUNTC ADDITIONAL LONG LEADS KIT: IEC9898031517812017-04-28
00884838025479NOUNPW TC20 10-Lead Patient Cable IEC9898031758912016-10-06
00884838025486NOUNPW TC20 10-Lead Patient Cable AHA9898031759012016-11-23
00884838025493NOUNPW TC20 Long 10-Lead Patient Cable IEC9898031759112016-11-03
00884838025509NOUNPW TC20 Long 10-Lead Patient Cable AHA9898031759212016-10-06
00884838029118NOUN12L Leadset, Grabber, AAMI9898031801212016-12-19
00884838029125NOUN12L Leadset, Grabber, IEC9898031801312016-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812559011136UNISTAT® Bilirubinometer Specimen CuvettesREICHERT, INC.MQM2025-08-12
00812559011143UNISTAT® Bilirubinometer Specimen CuvettesREICHERT, INC.MQM2025-08-12
00380740167561ARCHITECTABBOTT IRELANDMQM2024-08-15
00380740167578ARCHITECTABBOTT IRELANDMQM2024-08-15
00380740167585AlinityABBOTT IRELANDMQM2024-08-15
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSMQM2024-07-01
30884838096579BiliChekPhilips Medical Systems HsgMQM2022-10-21
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.MQM2020-04-15
00380740174965ARCHITECTAbbott GmbHMQM2020-04-12
00380740174972ARCHITECTAbbott GmbHMQM2020-04-12
00380740158415AlinityAbbott GmbHMQM2019-01-02
00380740158422AlinityAbbott GmbHMQM2019-01-02
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSMQM2018-09-21
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSMQM2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSMQM2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSMQM2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSMQM2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSMQM2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSMQM2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSMQM2018-09-21
05700699440570S4970 Rinse 1 Solution for 600mL, for ABL7xxRadiometer Medical ApSMQM2018-09-21
05700699441232Cleaning Solution with additive S7375 REF 944-123Radiometer Medical ApSMQM2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSMQM2018-09-21
05700699441300Rinse Solution S4980 REF 944-130Radiometer Medical ApSMQM2018-09-21
05700699441553Rinse Solution II S4987 REF 944-155 600mLRadiometer Medical ApSMQM2018-09-21
08426950807544GEM Premier 5000 PAK BG/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807568GEM Premier 5000 PAK BG/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24