FDA.reportPublic FDA data

EmbraceWAVE+ Pre-Pack (3x24)

Primary DI
00894030002277
Brand
EmbraceWAVE+ Pre-Pack (3x24)
Company
OMNIS HEALTH, LLC
Model
APX04AB0400BTPR
Catalog number
APX04AB0400BTPR
Device description
EmbraceWAVE+ Blood Glucose Meter x 3EmbraceWAVE Blood Glucose Test Strips 50ct. x 24
Published
2023-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical 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
00894030002277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894030002277008940300022778940300022770894030002277

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
Serial number
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
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
00894030002512Embrace Safety LancetSHN02GX21.222021-07-05

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