AirFloat Static Air Seat Cushion AF1717P

GUDID 10810006683537

AirFloat Static Air Seat Cushion (17"x17") with pump

PRIMO INC

Freestanding patient positioner, single-use

• Primary Device ID: 10810006683537
• NIH Device Record Key: 6a0c3249-9d48-4a06-815a-b4942307e29a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirFloat Static Air Seat Cushion
• Version Model Number: AF1717P
• Catalog Number: AF1717P
• Company DUNS: 958758146
• Company Name: PRIMO 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00810006683530 [Primary]
GS1	10810006683537 [Package]; Contains: 00810006683530; Package: Each [12 Units]; In Commercial Distribution

FDA Product Code

• FMP: Protector, Skin 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: 2021-08-03
• Device Publish Date: 2021-07-26

On-Brand Devices [AirFloat Static Air Seat Cushion]

• 10810006684121: AirFloat Static Air Seat Cushion Bariatric (28"x22") with pump
• 10810006684114: AirFloat Static Air Seat Cushion (19"x19") with pump
• 10810006683537: AirFloat Static Air Seat Cushion (17"x17") with pump
• 10810006683520: AirFloat Static Air Seat Cushion (17"x17")