GUDID 04913616090308

Canister for VT•100 - 300ml lock

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 04913616090308
• NIH Device Record Key: c86cef66-8463-4196-ae79-0909fe3b13ad
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S1001-6060
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713616093651 [Primary]
GS1	04713616094740 [Package]; Package: [9 Units]; In Commercial Distribution
GS1	04913616090308 [Package]; Contains: 04713616093651; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112853

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-22

Devices Manufactured by CARILEX MEDICAL, INC.

• 04719873696857 - NA: 2023-12-12 VT•200 P.U. Global Med One
• 04719873696864 - NA: 2023-12-12 VT•200 SYS Global Med One
• 14713616094785 - NA: 2023-09-18 Envelop Cover 42'' × 80'' QLT-1p
• 04713616094764 - NA: 2023-09-06 Envelop M-set 42'' × 80'' QLT Carilex
• 04719873692972 - NA: 2022-08-23 TheraFlo 9 M-set 90 x 200cm WDTX Carilex
• 00471987369297 - NA: 2022-08-01 TheraFlo 9 M-set 90 x 200cm WDTX Carilex
• 04719873692989 - NA: 2022-08-01 TheraFlo 9 M-set 107 x 200cm DTX Carilex
• 04719873693108 - NA: 2022-08-01 TheraFlo 7 & 9 Cover 90 x 200cm WDTX Carilex-1p