GUDID 04713616094603

VT Port Set Kit

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system foam dressing, non-antimicrobial

• Primary Device ID: 04713616094603
• NIH Device Record Key: 85d3c7d8-ec21-4c57-8b72-97d0d089c2d7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S1001-8160
• Company DUNS: 658863238
• Company Name: CARILEX MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713616094597 [Primary]
GS1	04713616094603 [Package]; Contains: 04713616094597; Package: [15 Units]; In Commercial Distribution
GS1	04713616094610 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	14713616094594 [Package]; Contains: 04713616094597; Package: [15 Units]; In Commercial Distribution
GS1	24713616094591 [Package]; Contains: 14713616094594; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172725

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-24
• Device Publish Date: 2021-03-16

Devices Manufactured by CARILEX MEDICAL, INC.

• 04719873698608 - NA: 2025-12-30 Envelop M-set 42" 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)