Embrace Lancet

GUDID 00894030002048

Embrace Lancet 30G

OMNIS HEALTH, LLC

Blood lancet, single-use
Primary Device ID00894030002048
NIH Device Record Keyb0f41f79-8f19-4b6d-a905-26987fbf70db
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbrace Lancet
Version Model NumberSHN02GM0123
Company DUNS824763358
Company NameOMNIS HEALTH, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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 Dimensions

Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100894030002048 [Primary]

FDA Product Code

FMKLancet, Blood
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-09
Device Publish Date2021-07-01

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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