HealthWise Embrace TALK Blood Glucose Monitoring System (Meter Only)

GUDID 00894030002819

OMNIS HEALTH, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00894030002819
• NIH Device Record Key: 84da5f41-58b0-4e59-a215-0bca916722cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthWise Embrace TALK Blood Glucose Monitoring System (Meter Only)
• Version Model Number: APX03AB0312HW
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00894030002819 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02

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.