Embrace TALK Blood Glucose Monitor

GUDID 00894030002000

Meter Only

OMNIS HEALTH, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00894030002000
• NIH Device Record Key: 0aee2493-7e97-44c1-93e0-be37ff9e276b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embrace TALK Blood Glucose Monitor
• Version Model Number: APX03AB0300
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894030002000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090043

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-18
• Device Publish Date: 2019-10-29

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 @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.