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 ID10015961687105
NIH Device Record Key9df54c94-3aa2-45e1-8ad1-0a06109ea7dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAGILE
Version Model Number4"x10"
Catalog Number3000119993
Company DUNS963905539
Company NameMILLIKEN HEALTHCARE PDTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch
Area/Surface Area40 Square inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100015961687108 [Primary]
GS110015961687105 [Package]
Contains: 00015961687108
Package: Shelf box [2 Units]
In Commercial Distribution
GS120015961687102 [Package]
Package: Shipper [5 Units]
In Commercial Distribution

FDA Product Code

NACDressing, Wound, Hydrophilic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-12
Device Publish Date2021-02-04

On-Brand Devices [AGILE]

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

Trademark Results [AGILE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AGILE
AGILE
97725199 not registered Live/Pending
Peak E-Commerce Inc.
2022-12-20
AGILE
AGILE
97254352 not registered Live/Pending
Agile Peripherals Inc.
2022-02-04
AGILE
AGILE
97057123 not registered Live/Pending
Diriye, Abdi
2021-10-01
AGILE
AGILE
97020225 not registered Live/Pending
Agile Trading Technologies, LLC
2021-09-09
AGILE
AGILE
90799301 not registered Live/Pending
Agile Space Industries, Inc.
2021-06-28
AGILE
AGILE
90721075 not registered Live/Pending
TK Elevator Innovation and Operations GmbH
2021-05-19
AGILE
AGILE
90022332 not registered Live/Pending
Boston Scientific Scimed, Inc.
2020-06-26
AGILE
AGILE
88625470 not registered Live/Pending
Essenlix Corporation
2019-09-20
AGILE
AGILE
88100740 not registered Live/Pending
Milliken Healthcare Products, LLC
2018-08-31
AGILE
AGILE
88046020 not registered Live/Pending
SHUMSKY THERAPEUTIC PILLOWS, LLC
2018-07-20
AGILE
AGILE
87807133 not registered Dead/Abandoned
Auto-Graphics, Inc.
2018-02-22
AGILE
AGILE
87629054 not registered Dead/Abandoned
Southern Perspective SZ Limited
2017-09-30

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