GUDID 04719873698615

Envelop M-set 48" x 80" VTX Carilex

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system

• Primary Device ID: 04719873698615
• NIH Device Record Key: 30c270b0-b18d-4cf2-bc30-06bfae5dd72e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S2003-2260
• 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	04719873698615 [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: 2025-12-30
• Device Publish Date: 2025-12-22

Devices Manufactured by CARILEX MEDICAL, INC.

• 04719873698608 - NA: 2025-12-30 Envelop M-set 42" x 80" VTX Carilex
• 04719873698615 - NA: 2025-12-30Envelop M-set 48" x 80" VTX Carilex
• 04719873698615 - NA: 2025-12-30 Envelop M-set 48" x 80" VTX Carilex
• 14719873698629 - NA: 2025-12-30 Envelop Cover 42" x 80" VTX Carilex-1p
• 14719873698636 - NA: 2025-12-30 Envelop Cover 48" x 80" VTX Carilex-1p
• 04719873693634 - NA: 2025-12-29 VT Drape and Port Set Kit S Lock
• 04719873693641 - NA: 2025-12-29 VT Drape and Port Set Kit M Lock
• 04719873693658 - NA: 2025-12-29 VT Drape and Port Set Kit L Lock
• 04719873698424 - NA: 2025-09-17 CariChair Carry Bag(single-layer)