Foam 10x12.5cm Pack 1 66801021

GUDID 00040565125909

A reticulated, open-cell, polyurethane foam dressing designed for Negative Pressure Wound Therapy (NPWT).

SMITH & NEPHEW MEDICAL LIMITED

Wound dressing kit, medicated, sterile Wound dressing kit, medicated, sterile Wound dressing kit, medicated, sterile Wound dressing kit, medicated, sterile Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated Wound dressing kit, medicated

• Primary Device ID: 00040565125909
• NIH Device Record Key: e4725718-1a3c-47f8-814d-5a9df00eaa06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foam 10x12.5cm Pack 1
• Version Model Number: 66801021
• Catalog Number: 66801021
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW 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: 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	00040565125909 [Primary]
GS1	30040565125900 [Package]; Package: case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142979

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

[00040565125909]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-10-15

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

• 05000223402464 - IV3000 6X8CM-CARTON OF 100: 2023-09-07 Moisture responsive IV catheter dressing
• 05000223049249 - IV3000 6X8.5CM-CARTON OF 10: 2023-09-07 Moisture responsive IV catheter dressing
• 05000223049256 - IV3000: 2023-09-07 Moisture responsive catheter dressing. 10cm x 14cm Ctn of 10
• 05000223463113 - OPSITE POST-OP VISIBLE 20X10CM CTN 20: 2023-09-07 Waterproof, bacteria proof dressing with absorbent see through pad
• 00040565122564 - IODOSORB: 2023-09-07 Cadexomer iodine gel. 10g. Ctn of 1 Tube
• 05000223500184 - RENASYS: 2023-09-07 Renasys XL Transparent Film Dressing
• 05000223500207 - RENASYS: 2023-09-07 Renasys-F XL Foam Dressing Kit With Soft Port
• 30040565118254 - IV3000: 2023-09-07 4” x 5” Non-Sterile Bulk