Air Float Static Air Seat Cushion AF282215

GUDID 00810006680188

Air Float Static Air Seat Cushion Bariatric (28"x22"x1.5")

PRIMO INC

Freestanding patient positioner, single-use

• Primary Device ID: 00810006680188
• NIH Device Record Key: f7cd6ec0-ee52-478e-a013-64a1329c3fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Float Static Air Seat Cushion
• Version Model Number: AF282215
• Catalog Number: AF282215
• 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	00810006680188 [Primary]
GS1	10810006680185 [Package]; 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: 2019-03-11
• Device Publish Date: 2019-02-20

On-Brand Devices [Air Float Static Air Seat Cushion]

• 00810006680188: Air Float Static Air Seat Cushion Bariatric (28"x22"x1.5")
• 00810006680171: Air Float Static Air Seat Cushion (19"x19"x1.5")
• 00810006680164: Air Float Static Air Seat Cushion (17"x17"x1.5")