AIROS

GUDID 10855682007178

8 Chamber Small Wide Leg Garment

AIROS MEDICAL INC

Multi-chamber venous compression system garment, single-use

• Primary Device ID: 10855682007178
• NIH Device Record Key: 15a50ba7-e95c-442d-833e-eea8a72336a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIROS
• Version Model Number: 8-SWL01
• Company DUNS: 080942280
• Company Name: AIROS MEDICAL INC
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)991-6956
• Email: dbehuniak@airosmedical.com

Device Dimensions

• Length: 26 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855682007171 [Primary]
GS1	10855682007178 [Package]; Contains: 00855682007171; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172779

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: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2019-11-01

On-Brand Devices [AIROS]

• 10855682007239: 8 Chamber Large Wide Leg Garment
• 10855682007222: 8 Chamber Large Leg Garment
• 10855682007215: 8 Chamber Medium Extra Wide Leg Garment
• 10855682007208: 8 Chamber Medium Wide Leg Garment
• 10855682007192: 8 Chamber Medium Leg Garment
• 10855682007185: 8 Chamber Small Extra Wide Leg Garment
• 10855682007178: 8 Chamber Small Wide Leg Garment
• 10855682007161: 8 Chamber Small Leg Garment
• 10855682007154: 6 Chamber Large Arm Garment
• 10855682007147: 6 Chamber Medium Arm Garment
• 10855682007130: 6 Chamber Half Wide Leg Garment
• 10855682007123: 6 Chamber Half Leg Garment
• 10855682007116: 6 Chamber Large Wide Leg Garment
• 10855682007109: 6 Chamber Large Leg Garment
• 10855682007093: 6 Chamber Medium Extra Wide Leg Garment
• 10855682007086: 6 Chamber Medium Wide Leg Garment
• 10855682007079: 6 Chamber Medium Leg Garment
• 10855682007062: 6 Chamber Small Extra Wide Leg Garment
• 10855682007055: 6 Chamber Small Wide Leg Garment
• 10855682007048: 6 Chamber Small Leg Garment
• 10855682007031: 8 Chamber Medium Arm Garment
• 10855682007024: 8 Chamber Large Arm Garment
• 00855682007010: AIROS 6 Sequential Compression Device
• 00855682007003: AIROS 8 Sequential Compression Device
• 10855682007352: 8 Chamber Arm Plus Left Pink Garment
• 10855682007345: 8 Chamber Arm Plus Right Pink Garment
• 10855682007338: 6 Chamber Arm Plus Left Pink Garment
• 10855682007321: 6 Chamber Arm Plus Right Pink Garment
• 10855682007314: 8 Chamber Arm Plus Right Garment
• 10855682007307: 8 Chamber Arm Plus Left Garment
• 10855682007291: 6 Chamber Arm Plus Right Garment
• 10855682007284: 6 Chamber Arm Plus Left Garment
• 00850031012592: AIROS 8 Sequential Compression Device (Peristaltic)
• 00850031012585: AIROS Arm Plus Expander (Right)
• 00850031012578: AIROS Arm Plus Expander (Left)
• 00850031012561: AIROS Arm Plus Expander (Right)
• 00850031012554: AIROS Arm Plus Expander (Left)
• 10850031012391: AIROS 8 Chamber Arm Plus Right (Cool Gray)
• 10850031012384: AIROS 8 Chamber Arm Plus Left (Cool Gray)
• 10850031012377: AIROS 8 Chamber Large Arm Garment (Cool Gray)
• 10850031012360: AIROS 8 Chamber Medium Arm Garment (Cool Gray)
• 10850031012353: AIROS 8 Chamber Large Pants Garment (Cool Gray)
• 10850031012346: AIROS 8 Chamber Medium Pants Garment (Cool Gray)
• 10850031012339: AIROS 8 Chamber Small Pants Garment (Cool Gray)
• 10850031012322: AIROS 8 Chamber Large Extra Wide Leg Garment (Cool Gray)
• 10850031012315: AIROS 8 Chamber Large Wide Leg Garment (Cool Gray)
• 10850031012308: AIROS 8 Chamber Large Leg Garment (Cool Gray)
• 10850031012292: AIROS 8 Chamber Medium Double Extra Wide Leg Garment (Cool Gray)
• 10850031012285: AIROS 8 Chamber Medium Extra Wide leg Garment (Cool Gray)
• 20850031012275: AIROS 8 Chamber Medium Wide Leg Garment (Cool Gray)