FDA.reportPublic FDA data

PolyMem

Primary DI
10735471024398
Brand
PolyMem
Company
FERRIS MFG. CORP.
Model
Silicone Border
Catalog number
2439
Device description
PolyMem Silicone Border Sacral Dressing
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMFBandage, Liquid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMFBandage, LiquidGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20735471024395PackageGS15In Commercial Distribution
30735471024392PackageGS14In Commercial Distribution
10735471024398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2073547102439520735471024395
3073547102439230735471024392
1073547102439810735471024398

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Excursions permitted less than 55 degrees celcius but should be minimized
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8007659636info@polymem.com

Regulatory Flags#

DUNS number
084733682
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10735471024695PolyMemSilicone Border24692026-01-14
20735471024692PolyMemSilicone Border24692026-01-14
10735471013316PolyMemWIC Silver13312020-08-31
10735471013330PolyMemWIC Silver13332020-08-31
10735471017888PolyMemWIC Silver17882020-08-31
10735471018144PolyMemWIC Silver18142020-08-31
10735471024664PolyMemSilicone Border24662022-12-28
10735471024992PolyMemSilicone Border24992022-12-28
10735471012494PolyMemSilicone Silver Border12492021-03-31
10735471012890PolyMemSilicone Silver Border12892021-03-31
10735471028396PolyMemSilicone Border28392021-03-31
20735471012491PolyMemSilicone Silver Border12492021-03-31
20735471012897PolyMemSilicone Silver Border12892021-03-31
20735471024395PolyMemSilicone Border24392021-03-31
20735471028393PolyMemSilicone Border28392021-03-31
10735471053336PolyMemShapes53332020-08-31
10735471053350PolyMemShapes53352020-08-31
10735471002037PolyMemPolyMem2032020-08-31
10735471002303PolyMemMAX02302020-08-31
10735471004000PolyMemNursicare400-US2020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253047967KendallCardinal Health 200, LLCKMF2026-05-26
10192253047974KendallCardinal Health 200, LLCKMF2026-05-13
10192253047943KendallCardinal Health 200, LLCKMF2026-05-12
10192253047950KendallCardinal Health 200, LLCKMF2026-05-12
007073878171523M™ Cavilon™3M COMPANYKMF2026-04-17
00858071004034Natural Seal Wound Dressing 1ozKericure Inc.KMF2025-10-03
00858071004256Advanced Seal Wound Barrier, 1oz sprayKericure Inc.KMF2025-08-21
00860013046415TearRepairOptmed IncKMF2025-05-30
10888277719743MedlineMEDLINE INDUSTRIES, INC.KMF2024-03-05
20888277719740MedlineMEDLINE INDUSTRIES, INC.KMF2024-03-05
10192253048087KendallCardinal Health 200, LLCKMF2024-03-04
10192253048094KendallCardinal Health 200, LLCKMF2024-03-04
10192253048100KendallCardinal Health 200, LLCKMF2024-03-04
10192253048117KendallCardinal Health 200, LLCKMF2024-03-04
20192253048084KendallCardinal Health 200, LLCKMF2024-03-04
20192253048091KendallCardinal Health 200, LLCKMF2024-03-04
20192253048107KendallCardinal Health 200, LLCKMF2024-03-04
20192253048114KendallCardinal Health 200, LLCKMF2024-03-04
10192253046908CurityCardinal Health 200, LLCKMF2023-11-03
20192253046905CurityCardinal Health 200, LLCKMF2023-11-03
10192253046861CurityCardinal Health 200, LLCKMF2023-10-25
10192253046885CurityCardinal Health 200, LLCKMF2023-10-25
20192253046875CurityCardinal Health 200, LLCKMF2023-10-25
20192253046868CurityCardinal Health 200, LLCKMF2023-10-25
20192253046882CurityCardinal Health 200, LLCKMF2023-10-25
30192253046872CurityCardinal Health 200, LLCKMF2023-10-25
10192253046847CurityCardinal Health 200, LLCKMF2023-10-24
10192253046854CurityCardinal Health 200, LLCKMF2023-10-24
20192253046844CurityCardinal Health 200, LLCKMF2023-10-24
20192253046851CurityCardinal Health 200, LLCKMF2023-10-24