ADAPTIC® 2019

GUDID 25051978000171

Non-Adhering Dressing

SYSTAGENIX WOUND MANAGEMENT, LIMITED

Wound-nonadherent dressing, permeable

• Primary Device ID: 25051978000171
• NIH Device Record Key: 2190f314-88b5-4e9b-a053-53ee3f19e98b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAPTIC®
• Version Model Number: 2019
• Catalog Number: 2019
• Company DUNS: 211352227
• Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED
• 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

• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter
• Width: 12.7 Centimeter
• Length: 22.9 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051978000174 [Primary]
GS1	25051978000171 [Package]; Contains: 15051978000174; Package: [12 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: 2019-10-02
• Device Publish Date: 2019-09-24

On-Brand Devices [ADAPTIC®]

• 25051978000232: Non-Adhering Dressing
• 35051978000222: Non-Adhering Dressing
• 25051978000195: Non-Adhering Dressing
• 25051978000171: Non-Adhering Dressing
• 25051978000164: Non-Adhering Dressing
• 25051978000133: Non-Adhering Dressing