Embrace TALK control solution HI

GUDID 00894030002864

Glucose monitoring system IVD, home-use

Primary Device ID	00894030002864
NIH Device Record Key	f6aab374-bc34-4752-829e-192ccf706658
Commercial Distribution Status	In Commercial Distribution
Brand Name	Embrace TALK control solution HI
Version Model Number	APX03AB0317
Company DUNS	824763358
Company Name	OMNIS HEALTH, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00894030002864 [Primary]

JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

Steralize Prior To Use	false
Device Is Sterile	false

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 @8mm	2022-12-07 Insulin pen needle 30G 8mm 100 ct.
00894030002055 - Embrace Pen Needle 31G @6mm	2022-12-07 Insulin pen needle 31G 6mm 100 ct.
00894030002109 - Embrace Pen Needle 29G @12mm	2022-12-07 Insulin pen needle 29G 12mm 100 ct.
00894030002116 - Embrace Pen Needle 31G @5mm	2022-12-07 Insulin pen needle 31G 5mm 100 ct.
00894030002123 - Embrace Pen Needle 31G @8mm	2022-12-07 Insulin pen needle 31G 8mm 100 ct.
00894030002130 - Embrace Pen Needle 32G @4mm	2022-12-07 Insulin pen needle 32G 4mm 100 ct.
00894030002529 - Embrace Pen Needle 30G @5mm	2022-12-07 Insulin pen needle 30G 5mm 100 ct.