AGILE 3000119993

GUDID 10015961687105

AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that provides moisture management and gelling fiber properties. AGILE is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, tunneling, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). AGILE consists of a white polyester/ lyocel wound contact layer and two blue Polyester/ Lyocell waffle knit fabrics laminated together. The blue side of the dressing is placed away from the wound.

MILLIKEN HEALTHCARE PDTS, LLC

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

• Primary Device ID: 10015961687105
• NIH Device Record Key: 9df54c94-3aa2-45e1-8ad1-0a06109ea7dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILE
• Version Model Number: 4"x10"
• Catalog Number: 3000119993
• 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

Device Dimensions

• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch
• Area/Surface Area: 40 Square inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015961687108 [Primary]
GS1	10015961687105 [Package]; Contains: 00015961687108; Package: Shelf box [2 Units]; In Commercial Distribution
GS1	20015961687102 [Package]; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

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: 2021-02-12
• Device Publish Date: 2021-02-04

On-Brand Devices [AGILE]

• 10015961687105: AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that pr
• 10015961687099: AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that pr
• 10015961687082: AGILE is a sterile, single-use conformable multi-layered wound dressing containing Lyocell that
• 10015961687075: AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that pr