FDA.reportPublic FDA data

Silicone Bandage

Primary DI
18800109203307
Brand
Silicone Bandage
Company
AP MDS Co., Ltd.
Model
ABST-1-1
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
18800109203307PackageGS112In Commercial Distribution
28800109203304PackageGS1216In Commercial Distribution
08800109203300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880010920330718800109203307
2880010920330428800109203304
08800109203300088001092033008800109203300

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
695407034
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08800109203362Silicone BandageABST-4-12024-04-19
08800109203379Silicone BandageABST-4-22024-04-19
08800109203386Silicone BandageABST-4-222024-04-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11