V.A.C.INSTILL®

GUDID 00878237001639

V.A.C. Instill Irrigation Set

KCI USA, INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00878237001639
• NIH Device Record Key: 7440f7be-7daf-4191-9598-562391d8797f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.C.INSTILL®
• Version Model Number: M6275413/5
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00878237001417 [Package]; Package: 5 PACK [5 Units]; In Commercial Distribution
GS1	00878237001639 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021501

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-20
• Device Publish Date: 2016-11-02

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