GUDID 04713616096379

TheraFlo 7 & 9 Cover 36" x 80" VTX Carilex-1p

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system

• Primary Device ID: 04713616096379
• NIH Device Record Key: a43122b3-ffc5-45fb-9ee8-6af9b03d1cbb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S2001-A780
• 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	04713616096362 [Primary]
GS1	04713616096379 [Package]; Contains: 04713616096362; Package: [10 Units]; In Commercial Distribution
GS1	14713616096369 [Package]; Contains: 04713616096362; Package: [10 Units]; In Commercial Distribution

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: 2022-03-09
• Device Publish Date: 2022-03-01

Devices Manufactured by CARILEX MEDICAL, INC.

• 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
• 04719873698356 - NA: 2025-08-28 AVA Cure M-set 42'' × 80'' TDX Carilex
• 04719873698363 - NA: 2025-08-28 AVA Cure M-set 36'' × 84'' TDX Carilex
• 04719873698370 - NA: 2025-08-28 AVA Cure M-set 42'' × 84'' TDX Carilex
• 14719873698384 - NA: 2025-08-28 AVA Cure Cover 36'' × 80'' TDX Carilex-1p
• 14719873698391 - NA: 2025-08-28 AVA Cure Cover 42'' × 80'' TDX Carilex-1p