AccessGUDID - DEVICE: AGILE (00015961687085)

GUDID

Device Identifier (DI) Information

Brand Name: AGILE
Version or Model: 2"x2"
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3000119991
Company Name: MILLIKEN HEALTHCARE PDTS, LLC

Primary DI Number: 00015961687085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 963905539 *Terms of Use

Device Description: AGILE is a 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/ lyocell 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43186	Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 4 Square inch

Device Record Status

Public Device Record Key: c13b33ba-6c8d-419b-8e51-29d8076c0a9c
Public Version Date: July 22, 2021
Public Version Number: 2
DI Record Publish Date: February 04, 2021