FDA.reportPublic FDA data

EmbraceEVO Gestational Diabetes Package - SMALL (5 vials)

Primary DI
00894030002475
Brand
EmbraceEVO Gestational Diabetes Package - SMALL (5 vials)
Company
OMNIS HEALTH
Model
APX01GS0100-S
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113208000GAL-1A BLOOD GLUCOSE MONITORING SYSTEMApex BioTechnology Corp.2012-01-26CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894030002475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894030002475008940300024758940300024750894030002475

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care blood glucose monitoring system IVDA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Regulatory Flags#

DUNS number
023891520
Device count
1
Serial number
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
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
00894030002574Embrace Gestational Diabetes - Strips Refill Bundle (4 vials)APX02GS0202RF2016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850075956784Refractrol SP 9.0 HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956807Refractrol SP HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075957286Refractrol SP LowLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956791Refractrol SP 6.0 LowLgc Clinical Diagnostics, Inc.JJX2026-07-28
10758750035847VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-07-21
00816042013652FORAFORA CARE INC.LFR2026-07-20
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14