FDA.reportPublic FDA data

Embrace Gestational Diabetes - Strips Refill Bundle (4 vials)

Primary DI
00894030002574
Brand
Embrace Gestational Diabetes - Strips Refill Bundle (4 vials)
Company
OMNIS HEALTH
Model
APX02GS0202RF
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894030002574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894030002574008940300025748940300025740894030002574

Regulatory Flags#

DUNS number
023891520
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894030002345Embrace EVO Control Solution, L1 (Low)APX02AB08102016-08-23
00894030002352Embrace EVO Strips, 50ct Vial - RETAILAPX02AB08022016-08-23
00894030002376Embrace EVO Control Solution, L2 (Medium)APX02AB08112016-08-23
00894030002390Embrace Pro MeterALL01AB02002016-08-23
00894030002406Embrace Pro Strips, 50-ct vialsALL02AB02022016-08-23
00894030002413Embrace Pro Control Solution (L1/Normal; L2/High)ALL02AB02102016-08-23
00894030002420Embrace EVO Mini Meter, all-in-one kit, RETAILAPX01AB08512016-08-23
00894030002475EmbraceEVO Gestational Diabetes Package - SMALL (5 vials)APX01GS0100-S2016-08-23
00894030002482EmbraceEVO Gestational Diabetes Package - LARGE (9 vials)APX01GS0100-L2016-08-23
00894030002543EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials)APX01AGS0100-SR2016-08-23
00894030002017Embrace Meter, Meter OnlyAPX01AB2002016-08-23
00894030002024Embrace Strips, 50ct Vial - Distributor partnerAPX02AB02022016-08-23
00894030002062Embrace Control Solution, L2 (High)APX02AB03112016-08-23
00894030002079Embrace Control Solution, L1 (Low)APX02AB3102016-08-23
00894030002086Embrace Strips, 10-ctAPX02AB02002016-08-23
00894030002260Embrace Meter Kit (w/10 ct)APX01AB03002016-08-23
00894030002338Embrace Strips, 50ct Vial - Mail Order (Yellow Band)APX02AB0202MO2016-08-23
00894030002536Embrace Meter Value Pack (incl. 50ct)APX01AK0200VK2016-08-23
00894030002550Embrace Gestational Diabetes Package - SMALL (5 vials)APX01GS0200-S2016-08-23
00894030002567Embrace Gestational Diabetes Package - LARGE (9 vials)APX01GS0200-L2016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730167Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00810227730174Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00810227730181Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00850070979375FondCircleFondCircle Inc.NBW2026-10-27
00850070979344FondCircleFondCircle Inc.NBW2026-10-26
00850070979351FondCircleFondCircle Inc.NBW2026-10-26
00850070979368FondCircleFondCircle Inc.NBW2026-10-26
00850011135921AccuTrakLgc Clinical Diagnostics, Inc.JJX2026-10-15
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
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
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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