VivaGuard VGD01-381

GUDID 00853483008038

VivaGuard Lancing Device

Able Diagnostics Inc

Manual blood lancing device, single-use

• Primary Device ID: 00853483008038
• NIH Device Record Key: 8403a377-8079-4100-9159-96c1a9a6bcb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaGuard
• Version Model Number: VGD01
• Catalog Number: VGD01-381
• Company DUNS: 080952036
• Company Name: Able Diagnostics Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 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	00853483008038 [Primary]

FDA Product Code

• FMK: Lancet, Blood

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: 2021-02-17
• Device Publish Date: 2021-02-09

On-Brand Devices [VivaGuard]

• 00853483008144: VivaGuard Lancets 100s (30G)
• 00853483008137: VivaGuard Safety Lancets (100s)
• 00853483008038: VivaGuard Lancing Device
• 00853483008021: VivaGuard Lancets 50s (30G)