VenaOne, Single Replacement Device

GUDID 00194832000373

Ortho8 Inc

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system

• Primary Device ID: 00194832000373
• NIH Device Record Key: e5103a66-b908-46d9-833b-9fa5fd30165a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VenaOne, Single Replacement Device
• Version Model Number: 08-0044
• Company DUNS: 115621579
• Company Name: Ortho8 Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00194832000359 [Primary]
GS1	00194832000373 [Package]; Contains: 00194832000359; Package: Box [20 Units]; In Commercial Distribution

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2022-11-28
• Device Publish Date: 2022-11-18

Devices Manufactured by Ortho8 Inc

• 01019483200028 - Circul8 Pro, Pair: 2022-11-28
• 10194832000035 - Luxe DVT, Pair: 2022-11-28
• 10194832000059 - Defender, Pair: 2022-11-28
• 01019483200073 - VenaPro, Pair: 2022-11-28
• 00194832000106 - VenaOne, Pair: 2022-11-28
• 10194832000110 - VenaOne, Charging Station with Battery Set: 2022-11-28
• 00194832000175 - VenaOne, Pair of Batteries: 2022-11-28
• 00194832000144 - VenaOne, Disposable Wraps, Box of 20 pairs: 2022-11-28