αCare SENS ACS-000000-LS

GUDID 07290114061186

ALPHA OMEGA ENGINEERING CO. LTD.

Medical equipment clinical data interfacing software

• Primary Device ID: 07290114061186
• NIH Device Record Key: e9bd0893-9da4-4465-8fd8-4790d814bf64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: αCare SENS
• Version Model Number: αCare SENS
• Catalog Number: ACS-000000-LS
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290114061186 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [αCare SENS]

• 07290114061186: αCare SENS
• 07290114061179: αCare SENS