Embrace TALK control solution HI

GUDID 00894030002864

Embrace TALK control solution L2

OMNIS HEALTH, LLC

Glucose monitoring system IVD, home-use
Primary Device ID00894030002864
NIH Device Record Keyf6aab374-bc34-4752-829e-192ccf706658
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbrace TALK control solution HI
Version Model NumberAPX03AB0317
Company DUNS824763358
Company NameOMNIS HEALTH, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100894030002864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-09
Device Publish Date2019-10-29

Devices Manufactured by OMNIS HEALTH, LLC

00894030002277 - EmbraceWAVE+ Pre-Pack (3x24)2023-03-31 EmbraceWAVE+ Blood Glucose Meter x 3 EmbraceWAVE Blood Glucose Test Strips 50ct. x 24
00894030002031 - Embrace Pen Needle 30G @8mm2022-12-07 Insulin pen needle 30G 8mm 100 ct.
00894030002055 - Embrace Pen Needle 31G @6mm2022-12-07 Insulin pen needle 31G 6mm 100 ct.
00894030002109 - Embrace Pen Needle 29G @12mm2022-12-07 Insulin pen needle 29G 12mm 100 ct.
00894030002116 - Embrace Pen Needle 31G @5mm2022-12-07 Insulin pen needle 31G 5mm 100 ct.
00894030002123 - Embrace Pen Needle 31G @8mm2022-12-07 Insulin pen needle 31G 8mm 100 ct.
00894030002130 - Embrace Pen Needle 32G @4mm2022-12-07 Insulin pen needle 32G 4mm 100 ct.
00894030002529 - Embrace Pen Needle 30G @5mm2022-12-07 Insulin pen needle 30G 5mm 100 ct.

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