ABTHERA™

GUDID 00849554000247

ABTHERA CANISTER

KCI USA, INC.

Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister Negative-pressure wound therapy system canister

• Primary Device ID: 00849554000247
• NIH Device Record Key: 0440ff41-70ad-4a39-9ad5-ddb47d3d08a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABTHERA™
• Version Model Number: 370620
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 20
• 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	00849554000247 [Primary]
GS1	00849554006492 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083357

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: 2018-08-15
• Device Publish Date: 2016-09-24

On-Brand Devices [ABTHERA™ ]

• 00849554001275: Abthera Tubing Set
• 00849554001268: Abthera Open Abdomen Dressing
• 00849554001237: Abthera Active Abdominal Therapy
• 00849554000247: ABTHERA CANISTER