GUDID 04719873693122

TheraFlo 7 & 9 Cover 107 x 200cm DTX Carilex-1p

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system

• Primary Device ID: 04719873693122
• NIH Device Record Key: 20e5e5bc-729c-427a-bd2e-02487240a4d7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S2001-A660
• 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	04719873693115 [Primary]
GS1	04719873693122 [Package]; Contains: 04719873693115; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• 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: 2022-08-01
• Device Publish Date: 2022-07-22

Devices Manufactured by CARILEX MEDICAL, INC.

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• 04719873698431 - NA: 2025-09-17 Dual GT M-set 85 x 200cm VTX Carilex
• 14719873698445 - NA: 2025-09-17 Dual GT Cover 85 x 200cm VTX Carilex-1p
• 14719873695741 - NA: 2025-09-15 VT Instill Port Set Kit
• 14719873695987 - NA: 2025-09-15 VT NX Port Set Kit
• 14719873698216 - NA: 2025-08-28 CariRaise Cover 20" x 75" TDX Carilex-1p
• 04719873698332 - NA: 2025-08-28 AVA Cure P.U. US Carilex
• 04719873698349 - NA: 2025-08-28 AVA Cure M-set 36'' × 80'' TDX Carilex