PREVENA DUO™ PEEL & PLACE™

GUDID 00849554006607

Prevena Duo Peel & Place System Kit- 13 cm

KCI USA, INC.

Negative-pressure wound therapy system, battery-powered, single-use

• Primary Device ID: 00849554006607
• NIH Device Record Key: 4eea9c09-e6d1-4c40-a13e-36f7d446ae79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVENA DUO™ PEEL & PLACE™
• Version Model Number: PRE1121US
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00849554006607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161897

FDA Product Code

• 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: 7
• Public Version Date: 2019-09-18
• Device Publish Date: 2017-05-09

Devices Manufactured by KCI USA, INC.

• 00849554008632 - 3M™ Snap™: 2024-10-03 3M™ Snap™ Therapy Strap, STPAM, Medium, 1 Each/Case
• 00849554008618 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Therapy Strap, STPAS, Small, 1 Each/Case
• 00849554008656 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Therapy Strap, STPAL, Large, 1 Each/Case
• 00849554008670 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPASP, Small, 1 Each/Case
• 00849554008694 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPAMP, Medium, 1 Each/Case
• 00849554008717 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPALP, Large, 1 Each/Case
• 00849554011762 - 3M™ V.A.C.®: 2024-08-19 ACTIV.A.C., CANISTER WITH GEL 10/CASE, ATHLONE, IH1078249, BSI MDR, 3M REBRANDING
• 00849554015401 - ActiV.A.C.™: 2024-08-08 ACTIV.A.C. CANISTER WITH GEL 10/CASE, ATHLONE, IH1078249, None, 3M REBRANDING, NON STERILE