ASSIST Silver Absorbent 3000117007

GUDID 10015961668647

ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver Absorbent is indicated for management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, lymphedema, dermatological wounds, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ASSIST Silver Absorbent dressings provide an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer coated with an ion-exchange silver, two layers of absorptive non-woven, and a grey occlusive outer layer. The film outer layer (side placed away from the wound) is grey and embossed. The embossing is a circle logo with "ASSIST Silver" printed inside. The logo has "This side away from wound," embossed above and below.

MILLIKEN HEALTHCARE PDTS, LLC

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 10015961668647
• NIH Device Record Key: 68439f25-3e11-4d41-9c89-cbaa481fb279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSIST Silver Absorbent
• Version Model Number: Vest
• Catalog Number: 3000117007
• Company DUNS: 963905539
• Company Name: MILLIKEN HEALTHCARE PDTS, LLC
• 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: true
• 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

Customer Support Contacts

• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com
• Phone: 18004326686
• Email: HealthcareCustomerService@Milliken.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015961668640 [Primary]
GS1	10015961668647 [Package]; Contains: 00015961668640; Package: Shipper case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083659

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: 2021-02-10
• Device Publish Date: 2021-02-02

On-Brand Devices [ASSIST Silver Absorbent]

• 10015961668647: ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
• 00015961668633: ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
• 00015961668626: ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
• 00015961664147: ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi
• 10015961293016: ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressi