Elite Balance Air Mattress

GUDID 00851675007159

Elite Balance Air Mattress (35")

CORK MEDICAL, LLC

Alternating-pressure bed mattress overlay system

• Primary Device ID: 00851675007159
• NIH Device Record Key: 104d0b25-3bfa-40a7-a7a2-984b14c463fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Balance Air Mattress
• Version Model Number: 6406-5
• Company DUNS: 015964214
• Company Name: CORK MEDICAL, LLC
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851675007159 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-02

On-Brand Devices [Elite Balance Air Mattress]

• 00851675007173: Elite Balance Air Max Mattress (48")
• 00851675007166: Elite Balance Air HD Mattress (42")
• 00851675007159: Elite Balance Air Mattress (35")