FDA.reportPublic FDA data

Blueline

Primary DI
00199536902145
Brand
Blueline
Company
Transparent Supply Solutions Ltd.
Model
2846P
Device description
Scrub Pants, SMS, Elastic Waist, 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
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel
OEANon-Surgical Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30199536902146PackageGS110In Commercial Distribution
50199536902140PackageGS16In Commercial Distribution
00199536902145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019953690214630199536902146
5019953690214050199536902140
00199536902145001995369021451995369021450199536902145

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
119522714
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199536902008Blueline2802T2026-05-15
00199536902015Blueline2803T2026-05-15
00199536902022Blueline2804T2026-05-15
00199536902039Blueline2805T2026-05-15
00199536902046Blueline2806T2026-05-15
00199536902053Blueline2807T2026-05-15
00199536902107Blueline2842P2026-05-15
00199536902114Blueline2843P2026-05-15
00199536902121Blueline2844P2026-05-15
00199536902138Blueline2845P2026-05-15
00199536902152Blueline2847P2026-05-15
00199536902206Blueline2812T2026-05-15
00199536902213Blueline2813T2026-05-15
00199536902220Blueline2814T2026-05-15
00199536902237Blueline2815T2026-05-15
00199536902244Blueline2816T2026-05-15
00199536902251Blueline2817T2026-05-15
00199536902305Blueline2852P2026-05-15
00199536902312Blueline2853P2026-05-15
00199536902336Blueline2855P2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10097604245002Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245057Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245101Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245200Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245309Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245354Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245408Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245453Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245507Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245552Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956007Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956052Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956106Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956205Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956304Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956359Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604546727Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2023-12-11
10097604546741Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2023-12-11
10097604245064Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245163Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245262Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245361Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245460Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245569Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245668Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245767Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245866Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28