FDA.reportPublic FDA data

EmbraceWAVE Blood Glucose Test Strips 25 ct.

Primary DI
00894030002208
Brand
EmbraceWAVE Blood Glucose Test Strips 25 ct.
Company
OMNIS HEALTH, LLC
Model
APX04AB0403
Device description
25 test strips/vial * 1
Published
2023-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220421000BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemApex BioTechnology Corp.2022-11-04NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894030002208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894030002208008940300022088940300022080894030002208

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA 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 for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Regulatory Flags#

DUNS number
824763358
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894030002031Embrace Pen Needle 30G @8mmSHN02MM30.08SHN02MM30.082022-11-29
00894030002055Embrace Pen Needle 31G @6mmSHN02MM31.06SHN02MM31.062022-11-29
00894030002109 Embrace Pen Needle 29G @12mmSHN02MM29.12SHN02MM29.122022-11-29
00894030002116Embrace Pen Needle 31G @5mmSHN02MM31.05SHN02MM31.052022-11-29
00894030002123Embrace Pen Needle 31G @8mmSHN02MM31.08SHN02MM31.082022-11-29
00894030002130Embrace Pen Needle 32G @4mmSHN02MM32.04SHN02MM32.042022-11-29
00894030002529Embrace Pen Needle 30G @5mmSHN02MM30.05SHN02MM30.052022-11-29
00894030002277EmbraceWAVE+ Pre-Pack (3x24)APX04AB0400BTPRAPX04AB0400BTPR2023-03-23
00894030002178EmbraceWAVE+ Blood Glucose MeterAPX04AB0400BT2023-01-11
00894030002185EmbraceWAVE+ Blood Glucose Monitoring System Starter KitAPX04AB0401BT2023-01-11
00894030002192EmbraceWAVE+ Blood Glucose Monitoring System Value PackAPX04AB0402BT2023-01-11
00894030002215EmbraceWAVE Blood Glucose Test Strips 50 ct.APX04AB04042023-01-11
00894030002222EmbraceWAVE Blood Glucose Test Strips 100 ct.APX04AB04052023-01-11
00894030002239EmbraceWAVE Glucose Control Solution Low (L1)APX04AB04062023-01-11
00894030002246EmbraceWAVE Glucose Control Solution High (L2)APX04AB04072023-01-11
00894030002093Embrace TALK Blood Glucose Monitor (Pre-Pack 3 x 15)APX03AB0301PREAPX03AB0301PRE2022-11-01
00894030002598HealthWise Embrace TALK Pre-Pack (3x15)APX03AB0313HWPRAPX03AB0313HWPR2022-10-27
00894030002048Embrace LancetSHN02GM01232021-07-01
00894030002611Embrace Blood Glucose MonitorAPX01AB0200N2021-09-23
00894030002512Embrace Safety LancetSHN02GX21.222021-07-05

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