airNEST orange

GUDID 00670482000289

Air Mattress System 80"x35" w. nylon cover

Umano Medical Inc

Low-air-loss bed

• Primary Device ID: 00670482000289
• NIH Device Record Key: fd37c2e1-85cd-419b-a5ff-f1f47042f356
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: airNEST orange
• Version Model Number: USTAOS-803508N-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	00670482000289 [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

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• 00670482000319: Air Mattress System 80"x35" w. polyurethane cover and CT plate sleeve.
• 00670482000302: Air Mattress System 80"x35" w. polyurethane cover
• 00670482000296: Air Mattress System 80"x35" w. nylon cover and CT plate sleeve.
• 00670482000289: Air Mattress System 80"x35" w. nylon cover