FDA.reportPublic FDA data

PolyMem

Primary DI
20735471053333
Brand
PolyMem
Company
FERRIS MFG. CORP.
Model
Shapes
Catalog number
5333
Device description
2.75" x 2.75" Shapes by PolyMem Tube Dressing
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
20735471053333PackageGS115In Commercial Distribution
30735471053330PackageGS12In Commercial Distribution
10735471053336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2073547105333320735471053333
3073547105333030735471053330
1073547105333610735471053336

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube dressing, sterileA sterile foam pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. 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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007659636info@polymem.com

Regulatory Flags#

DUNS number
084733682
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10735471024398PolyMemSilicone Border24392021-03-31
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253047981KendallCardinal Health 200, LLCKMF2026-06-09
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10192253048001KendallCardinal Health 200, LLCKMF2026-06-09
10192253048018KendallCardinal Health 200, LLCKMF2026-06-09
10192253048025KendallCardinal Health 200, LLCKMF2026-06-09
10192253048032KendallCardinal Health 200, LLCKMF2026-06-09
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
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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