airNEST orangeXi

GUDID 00670482000449

Air Mattress System 80"/84"/88"x36"/42"/48" x 10" w. polyurethane cover

Umano Medical Inc

Low-air-loss bed

• Primary Device ID: 00670482000449
• NIH Device Record Key: ed2d03af-9e78-404f-beaa-2fd662c70be6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: airNEST orangeXi
• Version Model Number: USTAOXiS-80X36X10D-BIL
• Company DUNS: 249675476
• Company Name: Umano Medical 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: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00670482000449 [Primary]

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure

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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [airNEST orangeXi]

• 00670482000449: Air Mattress System 80"/84"/88"x36"/42"/48" x 10" w. polyurethane cover
• 00670482000432: Air Mattress System 80"/84"/88"x36"/42"/48" x 10" w. nylon cover