ArterioFlow

GUDID 10879766005416

Intermittent Circulator

OAKWELL DISTRIBUTION, INC.

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 10879766005416
• NIH Device Record Key: e101d5df-d8eb-4df6-984f-22a9681b1d98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArterioFlow
• Version Model Number: 7502
• Company DUNS: 033337813
• Company Name: OAKWELL DISTRIBUTION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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	00879766005419 [Primary]
GS1	10879766005416 [Package]; Contains: 00879766005419; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102582

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-30

On-Brand Devices [ArterioFlow]

• 10879766005416: Intermittent Circulator
• 10879766005409: Intermittent Circulator