NEXA NPWT FLUID CONTAINER PACK

GUDID 15060826400035

Nexa NPWT Fluid Container Pack is used as a disposable receptacle for wound fluid.

NEXA MEDICAL LIMITED

Negative-pressure wound therapy system canister

• Primary Device ID: 15060826400035
• NIH Device Record Key: 4b7af9a5-b9af-4015-9f4f-2cbd1f6672c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXA NPWT FLUID CONTAINER PACK
• Version Model Number: 414-00-102
• Company DUNS: 221046947
• Company Name: NEXA MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060826400035 [Package]; Contains: 35060826400039; Package: Box [5 Units]; In Commercial Distribution
GS1	35060826400039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162610

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by NEXA MEDICAL LIMITED

• 15060826400004 - NEXA NPWT Device Kit: 2023-09-07 Nexa NPWT Device kit containing Nexa NPWT Device, Charger and carry case
• 15060826400059 - NEXA Drape: 2023-09-07 Single drape pieces
• 15060826400066 - Nexa Foam: 2023-09-07 Single piece of foam used in Nexa Dressing.
• 15060826400011 - NEXA NPWT DRESSING -125mmHg: 2023-09-07 Nexa NPWT dressing -125mmHg pressure level. To be used in conjunction with Nexa Device and Nexa Fluid Container Pack
• 15060826400035 - NEXA NPWT FLUID CONTAINER PACK: 2023-09-07Nexa NPWT Fluid Container Pack is used as a disposable receptacle for wound fluid.
• 15060826400035 - NEXA NPWT FLUID CONTAINER PACK: 2023-09-07 Nexa NPWT Fluid Container Pack is used as a disposable receptacle for wound fluid.