GUDID 04713616091879

AVA LAL P.U. US Carilex

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system

• Primary Device ID: 04713616091879
• NIH Device Record Key: 565d5783-f318-4b28-a8e8-7a86ae2b38db
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S2004-3071
• 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	04713616091879 [Primary]

FDA Product Code

• FNM: Mattress, Air Flotation, Alternating Pressure
• IOQ: Bed, Flotation Therapy, Powered

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: 2021-11-09
• Device Publish Date: 2021-11-01

Devices Manufactured by CARILEX MEDICAL, INC.

• 04719873696901 - NA: 2024-06-28 TheraFlo 9 M-set 36" x 80" WDTX Carilex
• 14719873696915 - NA: 2024-06-28 TheraFlo 9 Cover 36" x 80" WDTX Carilex-1p
• 04719873696925 - NA: 2024-06-28 TheraFlo 9 M-set 42" x 80" DTX Carilex
• 14719873696939 - NA: 2024-06-28 TheraFlo 9 Cover 42" x 80" DTX Carilex-1p
• 04719873696949 - NA: 2024-06-28 FIT M-Set 36" x 80" VTX Carilex
• 04719873696956 - NA: 2024-06-28 FIT M-Set 36" x 80" WDTX Carilex
• 04719873696963 - NA: 2024-06-28 FIT M-set 36" x 80" QLT Carilex
• 04719873696970 - NA: 2024-06-28 FIT M-Set 42" x 80" VTX Carilex