FDA.reportPublic FDA data

Blueline

Primary DI
00199536901223
Brand
Blueline
Company
Transparent Supply Solutions Ltd.
Model
2262
Device description
Shoe Cover, Non Skid, SPP, Blue, XX-Large
Published
2026-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXPCover, Shoe, Operating-Room

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30199536901224PackageGS1100In Commercial Distribution
50199536901228PackageGS13In Commercial Distribution
00199536901223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019953690122430199536901224
5019953690122850199536901228
00199536901223001995369012231995369012230199536901223

GMDN Terms#

Term, Definition table
TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699Support@gotss.com

Regulatory Flags#

DUNS number
119522714
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00199536901001Blueline23202026-05-15
00199536901018Blueline23212026-05-15
00199536901100Blueline21402026-05-15
00199536901117Blueline21412026-05-15
00199536901124Blueline21422026-05-15
00199536901131Blueline21432026-05-15
00199536901148Blueline21442026-05-15
00199536901155Blueline21482026-05-15
00199536901162Blueline21512026-05-15
00199536901179Blueline21612026-05-15
00199536901186Blueline21822026-05-15
00199536901209Blueline22602026-05-15
00199536901216Blueline22612026-05-15
00199536901230Blueline22802026-05-15
00199536901247Blueline22812026-05-15
00199536901254Blueline22822026-05-15
00199536901261Blueline22902026-05-15
00199536901278Blueline22912026-05-15
00199536901308Blueline23102026-05-15
00199536901315Blueline23112026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456217566JMUJMU DENTAL, INCFXP2026-07-07
00860012300792JMUJMU DENTAL, INCFXP2026-07-07
00199536901209BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901216BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901230BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901247BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901254BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901261BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
00199536901278BluelineTransparent Supply Solutions Ltd.FXP2026-05-15
20197344164049MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-30
20197344133120MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
20197344151575MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
10197344103973MEDLINEMEDLINE INDUSTRIES, INC.FXP2025-04-05
10810141933214VIVIT SupplyVivit Supply LLCFXP2024-11-29
10810141933221VIVIT SupplyVivit Supply LLCFXP2024-11-29
10850053289504SURGYCOSurgyco LLCFXP2024-08-09
20197344036117MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344074454MedlineMEDLINE INDUSTRIES, INC.FXP2024-02-16
20197344036049MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344036056MedlineMEDLINE INDUSTRIES, INC.FXP2024-01-01
20197344029607MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-22
20197344029614MedlineMEDLINE INDUSTRIES, INC.FXP2023-12-19
30080196745795MedlineMEDLINE INDUSTRIES, INC.FXP2023-10-12
10810141930435VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930442VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930626Vivit SupplyVivit Supply LLCFXP2023-09-15
10810141930633VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930923VIVIT SupplyVivit Supply LLCFXP2023-09-15
10810141930930VIVIT SupplyVivit Supply LLCFXP2023-09-15
10097604459546Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXP2023-08-28