ALLEVYN AG HEEL INTERNATIONAL 66800098

GUDID 05000223461935

Non-Adhesive antimicrobial hydrocellular heel dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 05000223461935
• NIH Device Record Key: d5331695-1834-433f-8195-e7669d3a68c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLEVYN AG HEEL INTERNATIONAL
• Version Model Number: 66800098
• Catalog Number: 66800098
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• 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: true
• 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	05000223461928 [Primary]
GS1	05000223461935 [Package]; Contains: 05000223461928; Package: Carton [5 Units]; In Commercial Distribution
GS1	05000223462666 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063835

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2020-05-25
• Device Publish Date: 2020-05-15

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