ASSIST Absorbent

Basic Information

• Brand Name: ASSIST Absorbent
• Primary DI: 00015961293002
• Version / Model: 24"x36"
• Catalog Number: 3000004622
• Company Name: MILLIKEN HEALTHCARE PDTS, LLC
• Labeler DUNS: 963905539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-02
• Public Version: 1
• Public Version Date: 2021-02-10
• Public Version Status: New
• Public Device Record Key: 39d76d54-a7af-452e-a2c2-b4497872eb2b

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPY	Sheet, Burn	General Hospital	880.5180	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10015961293009	GS1	Shipper case	25	In Commercial Distribution
Primary	00015961293002	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 131 Degrees Fahrenheit