ASSIST Absorbent 3000004622

GUDID 10015961293009

ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST 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. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer, two layers of absorptive non-woven, and a white occlusive outer layer.

MILLIKEN HEALTHCARE PDTS, LLC

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• Primary Device ID: 10015961293009
• NIH Device Record Key: 39d76d54-a7af-452e-a2c2-b4497872eb2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSIST Absorbent
• Version Model Number: 24"x36"
• Catalog Number: 3000004622
• Company DUNS: 963905539
• Company Name: MILLIKEN HEALTHCARE PDTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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	00015961293002 [Primary]
GS1	10015961293009 [Package]; Contains: 00015961293002; Package: Shipper case [25 Units]; In Commercial Distribution

FDA Product Code

• FPY: Sheet, Burn

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

Devices Manufactured by MILLIKEN HEALTHCARE PDTS, LLC

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• 10015961687082 - AGILE: 2021-02-12 AGILE is a sterile, single-use conformable multi-layered wound dressing containing Lyocell that provides moisture management and
• 10015961687099 - AGILE: 2021-02-12 AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that provides moisture management and g
• 10015961687105 - AGILE: 2021-02-12 AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that provides moisture management and g
• 10015961293009 - ASSIST Absorbent: 2021-02-10ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST 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. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer, two layers of absorptive non-woven, and a white occlusive outer layer.
• 10015961293009 - ASSIST Absorbent: 2021-02-10 ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Absorbent is indicated for m
• 10015961293016 - ASSIST Silver Absorbent: 2021-02-10 ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver Absorbent is i
• 10015961464355 - ASSIST Silver: 2021-02-10 ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low
• 00015961464365 - ASSIST Silver: 2021-02-10 ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low