GUDID 14713616094785

Envelop Cover 42'' × 80'' QLT-1p

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 Alternating-pressure bed mattress overlay system

• Primary Device ID: 14713616094785
• NIH Device Record Key: 395b7d00-7173-4eb5-9508-960dcf243f0f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S2003-A220
• 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: true
• Serial Number: false
• 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	04713616094788 [Primary]
GS1	14713616094785 [Package]; Contains: 04713616094788; Package: [10 Units]; In Commercial Distribution

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: 2023-09-18
• Device Publish Date: 2023-09-08

Devices Manufactured by CARILEX MEDICAL, INC.

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• 04719873696864 - NA: 2023-12-12 VT•200 SYS Global Med One
• 14713616094785 - NA: 2023-09-18Envelop Cover 42'' × 80'' QLT-1p
• 14713616094785 - NA: 2023-09-18 Envelop Cover 42'' × 80'' QLT-1p
• 04713616094764 - NA: 2023-09-06 Envelop M-set 42'' × 80'' QLT Carilex
• 04719873692972 - NA: 2022-08-23 TheraFlo 9 M-set 90 x 200cm WDTX Carilex
• 00471987369297 - NA: 2022-08-01 TheraFlo 9 M-set 90 x 200cm WDTX Carilex
• 04719873692989 - NA: 2022-08-01 TheraFlo 9 M-set 107 x 200cm DTX Carilex
• 04719873693108 - NA: 2022-08-01 TheraFlo 7 & 9 Cover 90 x 200cm WDTX Carilex-1p