GUDID 04713616092104

Entrix NX P.U. US Carilex

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system

• Primary Device ID: 04713616092104
• NIH Device Record Key: 989507ad-72ea-4001-8219-59ea9d13ead3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S2202-3181
• Company DUNS: 658863238
• Company Name: CARILEX 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	04713616092104 [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: 2022-03-09
• Device Publish Date: 2022-03-01

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