GUDID 04713616090087

Canister for VT•100 - 300ml

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 04713616090087
• NIH Device Record Key: d1bd62da-6059-437f-aa7d-b6251b062b35
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S1001-6010
• 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	04713616090087 [Package]; Contains: 04713616093606; Package: [5 Units]; In Commercial Distribution
GS1	04713616093606 [Primary]
GS1	04713616094696 [Package]; 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

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