V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING

GUDID 20849554007189

V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING - LARGE

KCI USA, INC.

Negative-pressure wound therapy system foam dressing

• Primary Device ID: 20849554007189
• NIH Device Record Key: d18cb858-5b5c-4433-9e01-3624d054bfa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING
• Version Model Number: DTGF05PKL, DTGF10PKL
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00849554007185 [Primary]
GS1	10849554007182 [Package]; Contains: 00849554007185; Package: 5 Pack [5 Units]; In Commercial Distribution
GS1	20849554007189 [Package]; Contains: 00849554007185; Package: 10 Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181505

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING]

• 20849554007202: V.A.C. DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING - MEDIUM
• 20849554007196: V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING - SMALL
• 20849554007189: V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING - LARGE