GUDID 04713616090261

Canister for VT•100 - 1000ml lock

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 04713616090261
• NIH Device Record Key: 58c912c0-89da-40e8-bfa6-36b34a1f7d8d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S1001-6040
• 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: 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	04713616090261 [Package]; Contains: 04713616093637; Package: [5 Units]; In Commercial Distribution
GS1	04713616093637 [Primary]
GS1	04713616094726 [Package]; Package: [9 Units]; In Commercial Distribution
GS1	14713616093634 [Package]; Contains: 04713616093637; Package: [5 Units]; In Commercial Distribution
GS1	24713616093631 [Package]; Contains: 14713616093634; Package: [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112853

FDA Product Code

• KDQ: Bottle, Collection, Vacuum
• 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: 4
• Public Version Date: 2020-03-31
• Device Publish Date: 2017-03-22

Devices Manufactured by CARILEX MEDICAL, INC.

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• 14719873696915 - NA: 2024-06-28 TheraFlo 9 Cover 36" x 80" WDTX Carilex-1p
• 04719873696925 - NA: 2024-06-28 TheraFlo 9 M-set 42" x 80" DTX Carilex
• 14719873696939 - NA: 2024-06-28 TheraFlo 9 Cover 42" x 80" DTX Carilex-1p
• 04719873696949 - NA: 2024-06-28 FIT M-Set 36" x 80" VTX Carilex
• 04719873696956 - NA: 2024-06-28 FIT M-Set 36" x 80" WDTX Carilex
• 04719873696963 - NA: 2024-06-28 FIT M-set 36" x 80" QLT Carilex
• 04719873696970 - NA: 2024-06-28 FIT M-Set 42" x 80" VTX Carilex