FDA.reportPublic FDA data

HealthWise Embrace TALK Blood Glucose Test Strips (50 ct.)

Primary DI
00894030002833
Brand
HealthWise Embrace TALK Blood Glucose Test Strips (50 ct.)
Company
OMNIS HEALTH, LLC
Model
APX03AB0314HW
Published
2019-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090043000AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9Apex BioTechnology Corp.2009-04-09CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894030002833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894030002833008940300028338940300028330894030002833

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.

Sterilization Methods#

Method table
Method

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
00894030002208EmbraceWAVE Blood Glucose Test Strips 25 ct.APX04AB04032023-01-11
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

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