Aircast

GUDID 30817357021111

Aircast VenaFlow Elite Calf Cuff XL

HYGIA HEALTH SERVICES, INC.

Single-chamber venous compression system garment, reprocessed

• Primary Device ID: 30817357021111
• NIH Device Record Key: c1fa3c1d-47c8-4290-a9a6-6a9958d8eabb
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aircast
• Version Model Number: 3042
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	10817357021117 [Primary]
GS1	30817357021111 [Package]; Contains: 10817357021117; Package: Box [5 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053575

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: 4
• Public Version Date: 2021-03-19
• Device Publish Date: 2016-09-24

On-Brand Devices [Aircast]

• 30817357022330: Aircast VenaFlow Elite Bariatric Calf Cuff
• 30817357021555: Aircast VenaFlow Elite Foot Cuff
• 30817357021326: Aircast VenaFlow Foot Cuff, POSI LOCK
• 30817357021111: Aircast VenaFlow Elite Calf Cuff XL
• 30817357020947: Aircast VenaFlow Elite Foam Calf Cuff
• 30817357020770: Aircast VenaFlow Calf Cuff, POSI LOCK
• 30817357020121: Aircast VenaFlow Elite Calf Cuff