SENSAT.R.A.C.™

GUDID 00878237001141

Sensatrac Pad

KCI USA, INC.

Negative-pressure wound therapy tubing set

• Primary Device ID: 00878237001141
• NIH Device Record Key: 53cc1ad8-13d2-4d6c-b40b-3e798999ac76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSAT.R.A.C.™
• Version Model Number: M8275057/10
• 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	00878237001134 [Package]; Package: 10 Pack [10 Units]; In Commercial Distribution
GS1	00878237001141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062227

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: 2018-08-02
• Device Publish Date: 2017-11-22

On-Brand Devices [SENSAT.R.A.C.™ ]

• 00878237001141: Sensatrac Pad
• 00849554002531: Sensatrac Pad