FDA.reportPublic FDA data

Silicone Bandage

Primary DI
08800109203362
Brand
Silicone Bandage
Company
AP MDS Co., Ltd.
Model
ABST-4-1
Device description
A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed to cover a surface (e.g. a small wound), secure a dressing, or attach an object/device to the body. The silicone layer is designed to cause less allergy, cause less skin trauma than traditional pressure-sensitive adhesives, and has low adhesion to body hair for easy removal. This is a disposable device. Available in 1-inch, 2-inch, and 4-inch widths.
Published
2024-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800109203369PackageGS16In Commercial Distribution
28800109203366PackageGS154In Commercial Distribution
08800109203362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880010920336918800109203369
2880010920336628800109203366
08800109203362088001092033628800109203362

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, siliconeA long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
818 903 0660dpaek.rennes@gmail.com

Regulatory Flags#

DUNS number
694741911
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088001092015352Way Foley Balloon CatheterAPO-FC-0112022-02-10
088001092015422Way Foley Balloon CatheterAPO-FC-0102022-02-10
088001092015592Way Foley Balloon CatheterAPO-FC-0092022-02-11
088001092015662Way Foley Balloon CatheterAPO-FC-0082022-02-11
088001092015732Way Foley Balloon CatheterAPO-FC-0072022-02-11
088001092015803Way Foley Balloon CatheterAPO-FC-3142022-02-11
088001092015973Way Foley Balloon CatheterAPO-FC-3162022-02-11
088001092016033Way Foley Balloon CatheterAPO-FC-3182022-02-11
088001092016103Way Foley Balloon CatheterAPO-FC-3202022-02-11
088001092016273Way Foley Balloon CatheterAPO-FC-3222022-02-11
088001092016343Way Foley Balloon CatheterAPO-FC-3242022-02-11
08800109203300Silicone BandageABST-1-12024-04-19
08800109203317Silicone BandageABST-1-22024-04-19
08800109203324Silicone BandageABST-1-32024-04-19
08800109203331Silicone BandageABST-2-12024-04-19
08800109203348Silicone BandageABST-2-22024-04-19
08800109203355Silicone BandageABST-2-32024-04-19
08800109203379Silicone BandageABST-4-22024-04-19
08800109203386Silicone BandageABST-4-222024-04-19
08800109203393Silicone BandageABST-4-32024-04-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
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08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
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00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25