ASSIST Absorbent 3000004622

GUDID 10015961293009

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.

MILLIKEN HEALTHCARE PDTS, LLC

Wound-nonadherent dressing, absorbent, non-antimicrobial
Primary Device ID10015961293009
NIH Device Record Key39d76d54-a7af-452e-a2c2-b4497872eb2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSIST Absorbent
Version Model Number24"x36"
Catalog Number3000004622
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

Customer Support Contacts

Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com
Phone18004326686
EmailHealthcareCustomerService@Milliken.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100015961293002 [Primary]
GS110015961293009 [Package]
Contains: 00015961293002
Package: Shipper case [25 Units]
In Commercial Distribution

FDA Product Code

FPYSheet, Burn

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

Devices Manufactured by MILLIKEN HEALTHCARE PDTS, LLC

10015961687075 - AGILE2021-02-12 AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that provides moisture management and g
10015961687082 - AGILE2021-02-12 AGILE is a sterile, single-use conformable multi-layered wound dressing containing Lyocell that provides moisture management and
10015961687099 - AGILE2021-02-12 AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that provides moisture management and g
10015961687105 - AGILE2021-02-12 AGILE is sterile, single use conformable multi-layered wound dressing containing Lyocell that provides moisture management and g
10015961293009 - ASSIST Absorbent2021-02-10ASSIST 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.
10015961293009 - ASSIST Absorbent2021-02-10 ASSIST Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Absorbent is indicated for m
10015961293016 - ASSIST Silver Absorbent2021-02-10 ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver Absorbent is i
10015961464355 - ASSIST Silver2021-02-10 ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low
00015961464365 - ASSIST Silver2021-02-10 ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.