Air Float Static Air Mattress Overlay AF76473

GUDID 00810006680201

Air Float Static Air Mattress Overlay Bariatric (76"x47"'x3")

PRIMO INC

Freestanding patient positioner, single-use

• Primary Device ID: 00810006680201
• NIH Device Record Key: a2fe78b6-f5c2-4047-bb85-bf83b4c60a25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Float Static Air Mattress Overlay
• Version Model Number: AF76473
• Catalog Number: AF76473
• 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	00810006680201 [Primary]

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 Mattress Overlay]

• 00810006680201: Air Float Static Air Mattress Overlay Bariatric (76"x47"'x3")
• 00810006680195: Air Float Static Air Mattress Overlay ( 76"x34"x3")