GUDID 04719873691296

VT•200-i SYS Global Carilex

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 04719873691296
• NIH Device Record Key: af137e31-6721-48f9-b55f-215ddd01e903
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S1002-0022
• Company DUNS: 658863238
• Company Name: CARILEX MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873691296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231646

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

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: 2024-04-30
• Device Publish Date: 2024-04-22

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