ASSIST Silver Absorbent

Primary DI
00015961668640
Brand
ASSIST Silver Absorbent
Company
MILLIKEN HEALTHCARE PDTS, LLC
Model
Vest
Catalog number
3000117007
Device description
"ASSIST Silver Absorbent is a sterile, single use multi-layer low-adherent absorbent wound dressing. ASSIST Silver 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. ASSIST Silver Absorbent dressings provide an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a low-adherent veil wound contact layer, a polyester/ nylon wound contact layer coated with an ion-exchange silver, two layers of absorptive non-woven, and a grey occlusive outer layer. The film outer layer (side placed away from the wound) is grey and embossed. The embossing is a circle logo with ""ASSIST Silver"" printed inside. The logo has ""This side away from wound,"" embossed above and below."
Published
2021-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083659000SILVER WOUND PADMilliken & Co.2009-04-16FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015961668647PackageGS110In Commercial Distribution
00015961668640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001596166864710015961668647
00015961668640000159616686400159616686400015961668640

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
18004326686HealthcareCustomerService@Milliken.com

Regulatory Flags#

DUNS number
963905539
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015961687078AGILE"4""x4"""30001172222021-02-04
00015961687085AGILE"2""x2"""30001199912021-02-04
00015961687092AGILE"Pre-cut 4""x4"""30001199922021-02-04
00015961687108AGILE"4""x10"""30001199932021-02-04
00015961293026ULTRA"4""x5"""30000068402021-01-06
00015961477952TRITEC"4""x5"""30000200402021-02-01
00015961477969TRITEC"4""x48"""30000200512021-02-01
00015961649717ULTRA"8""x20"""30001122212021-01-06
00015961650041TRITEC"Pre-Cut 4""x5"""30001128162021-02-01
00015961669197ULTRA Border "3""x3"""30001168772021-01-06
00015961669203ULTRA Border "4""x10"""30001168802021-01-06
00015961669210ULTRA Border "4""x4"""30001168782021-01-06
00015961669227ULTRA Border "6""x6"""30001168792021-01-06
10015961687075AGILE4"x4"30001172222021-02-04
10015961687082AGILE2"x2"30001199912021-02-04
10015961687099AGILEPre-cut 4"x4"30001199922021-02-04
10015961687105AGILE4"x10"30001199932021-02-04
00015961293002ASSIST Absorbent"24""x36"""30000046222021-02-02
00015961293019ASSIST Silver Absorbent"24""x36"""30000069642021-02-02
00015961464358ASSIST Silver"4""x48"""30000511752021-02-02

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