FDA.reportPublic FDA data

Health Supply US Level 2 Gown

Primary DI
00381342000751
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
Rx
false
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117465816
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00381342000454Health Supply US Level 2 GownHSUS-L2-EC-LHSUS-L2-EC-L2024-06-18
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
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
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10197106796115CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106744192CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26