FDA.reportPublic FDA data

Health Supply US Level 2 Gown

Primary DI
00381342000454
Brand
Health Supply US Level 2 Gown
Company
Health Supply US, LLC
Model
HSUS-L2-EC-L
Catalog number
HSUS-L2-EC-L
Device description
Package of 10 single-use, non-sterile L2 SMS isolation gowns - gowns are not sold individually.
Published
2024-06-18
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
00381342000706PackageGS110In Commercial Distribution
00381342000713PackageGS112In Commercial Distribution
00381342000454PrimaryGS10
00381342000751Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381342000706003813420007063813420007060381342000706
00381342000713003813420007133813420007130381342000713
00381342000454003813420004543813420004540381342000454
00381342000751003813420007513813420007510381342000751

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
117465816
Device count
10
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381342000461Health Supply US Level 2 GownHSUS-L2-EC-XLHSUS-L2-EC-XL2024-06-18
00381342000577Health Supply US Level 2 GownHSUS-L2-EC-2XLHSUS-L2-EC-M2024-06-18
00381342000584Health Supply US Level 2 GownHSUS-L2-EC-MHSUS-L2-EC-M2024-06-18
00381342000591Health Supply US Level 2 GownHSUS-L2-EC-SHSUS-L2-EC-S2024-06-18
00381342000751Health Supply US Level 2 GownHSUS-L2-EC-LHSUS-L2-EC-L2024-06-18
00381342000744Health Supply US Level 2 GownHSUS-L2-EC-XLHSUS-L2-EC-XL2024-06-18
00381342000829Health Supply US Level 2 GownHSUS-L2-EC-2XLHSUS-L2-EC-M2024-06-18
00381342000799Health Supply US Level 2 GownHSUS-L2-EC-MHSUS-L2-EC-M2024-06-18
00381342000768Health Supply US Level 2 GownHSUS-L2-EC-SHSUS-L2-EC-S2024-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50080196247576MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109892MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40884389804637MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
50193489108239MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00199536901001BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901018BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901308BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901315BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901407BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901414BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901421BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901438BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901445BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901452BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901469BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901476BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00842942017506PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
00842942016530PRIMEDpriMED Medical Products IncOEA2025-07-21
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17