ULTRA 3000112221

GUDID 20015961649711

ULTRA is a sterile, single use foam wound dressing. ULTRA is indicated for low to highly exuding acute and chronic wounds such as partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV pressure ulcers, venous ulcers, and diabetic ulcers. The dressing has a polyester/ nylon wound contact layer, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with"Milliken" above and "ULTRA" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.

MILLIKEN HEALTHCARE PDTS, LLC

Exudate-absorbent dressing, non-gel, non-antimicrobial

• Primary Device ID: 20015961649711
• NIH Device Record Key: 4c177874-f542-4d5b-b217-155d51d04173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA
• Version Model Number: 8"x20"
• Catalog Number: 3000112221
• 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
• 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
• 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
• 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
• 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	00015961649717 [Primary]
GS1	10015961649714 [Package]; Contains: 00015961649717; Package: Shelf box [2 Units]; In Commercial Distribution
GS1	20015961649711 [Package]; Contains: 10015961649714; Package: Shipper case [5 Units]; In Commercial Distribution

FDA Product Code

• NAD: Dressing, Wound, Occlusive

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: 2021-01-14
• Device Publish Date: 2021-01-06

On-Brand Devices [ULTRA]

• 20015961649711: ULTRA is a sterile, single use foam wound dressing. ULTRA is indicated for low to highly exuding
• 10015961293023: ULTRA is a sterile, single use foam wound dressing. ULTRA is indicated for low to highly exuding