FDA.reportPublic FDA data

Blueline

Primary DI
00199536901308
Brand
Blueline
Company
Transparent Supply Solutions Ltd.
Model
2310
Device description
Cover Gown, Lightweight, Neck Tie, Yellow, Universal
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Gown

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30199536901309PackageGS110In Commercial Distribution
50199536901303PackageGS15In Commercial Distribution
00199536901308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019953690130930199536901309
5019953690130350199536901303
00199536901308001995369013081995369013080199536901308

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
00199536933705Blueline88072026-05-15
00199536933712Blueline88082026-05-15
00199536933729Blueline88092026-05-15
00199536933736Blueline88102026-05-15
00199536933743Blueline88112026-05-15
00199536933750Blueline88202026-05-15
00199536933767Blueline88212026-05-15
00199536933774Blueline88192026-05-15
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
00199536902145Blueline2846P2026-05-15
00199536902152Blueline2847P2026-05-15

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
10198956101395CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956101425CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956102163CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956099128CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101746CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101401CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956101906CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956089303CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-22
10197106988251CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-19
10198956089143CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-14
10197106988176CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-13
10197106824832CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106860120CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106873113CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-18
10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106868249CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106810477CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13