Embrace Lancet

GUDID 00894030002048

Embrace Lancet 30G

OMNIS HEALTH, LLC

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 00894030002048
• NIH Device Record Key: b0f41f79-8f19-4b6d-a905-26987fbf70db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embrace Lancet
• Version Model Number: SHN02GM0123
• Company DUNS: 824763358
• Company Name: OMNIS HEALTH, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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 Dimensions

• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894030002048 [Primary]

FDA Product Code

• FMK: Lancet, Blood
• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

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 @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.