FDA.reportPublic FDA data

Oracle

Primary DI
04719871820216
Brand
Oracle
Company
BIOTEST MEDICAL CORPORATION
Model
6268(BM6B268ROA)
Device description
Oracle Blood Glucose Monitoring System
Published
2016-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871820216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871820216047198718202164719871820216

GMDN Terms#

Term, Definition table
TermDefinition
Glucose analyser IVD, home-use/point-of-care, line-poweredA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-841-1109Ben.Coffey@nurserosie.com

Regulatory Flags#

DUNS number
658447255
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871820070Easy Plus II8818(BY8818G0NL4)2016-05-02
04719871820100Easy Plus II 8818(BZ8818G0HAB)2016-05-02
04719871820155Easy Talk8818(BZ8818G0HAA)2016-05-02
04719871820162Easy Talk8818(BY8818G0NL4)2016-05-02
04719871820230Oracle8818/BL8818ROA2016-11-29
04719871820261Perfect 388182017-02-23
04719871820339NuvoMed58192018-03-07
04719871820315NuvoMed P5228 BGM-6/0352 2018-03-07
04719871820322NuvoMed P5228 BGM-6/0352 2018-03-07
04719871820001Smartest PersonaII6276-S2016-03-02
04719871820018Smartest PersonaII 88192016-03-02
04719871820025Smartest PersonaIIGOD212016-03-02
04719871820032Smartest PersonaII 6276-S2016-03-02
04719871820049B T M82282016-03-02
04719871820056Easy Plus II6276-S(BZG60276HA)2016-05-02
04719871820063Easy Plus II6276-S(BYG60276HA)2016-05-02
04719871820087Easy Plus IIGOD11(BYGOD31BT)2016-05-02
04719871820094Easy Plus IIGOD31(BZL001HAB)2016-05-02
04719871820117Easy Plus IIGOD31(BZH002HAB)2016-05-02
04719871820124Easy Plus IIGOD11(BZL002HAB)2016-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750035823VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-08-26
00850011135884VALIDATELgc Clinical Diagnostics, Inc.JJX2026-08-25
04719869706966medisana BG 150 Blood Glucose MeterTYSON BIORESEARCH INC.NBW2026-08-19
04719869707000BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707017BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707024BG 150 Blood Glucose Test Strip(50T)TYSON BIORESEARCH INC.NBW2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJX2026-08-13
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCNBW2026-08-13
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCCGA2026-08-13
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30