FDA.reportPublic FDA data

Health Supply US Level 2 Gown

Primary DI
00381342000829
Brand
Health Supply US Level 2 Gown
Company
Health Supply US, LLC
Model
HSUS-L2-EC-2XL
Catalog number
HSUS-L2-EC-M
Device description
Pack of 10 Level 2 SMS non-sterile isolation gowns
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
00381342000829PackageGS110In Commercial Distribution
00381342000836PackageGS112In Commercial Distribution
00381342000577PrimaryGS10
00381342000812Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381342000829003813420008293813420008290381342000829
00381342000836003813420008363813420008360381342000836
00381342000577003813420005773813420005770381342000577
00381342000812003813420008123813420008120381342000812

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
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
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
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
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
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017278PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942007934PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942008047PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009570PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009587PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014406PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014420PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015298PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015427PRIMEDpriMED Medical Products IncOEA2025-07-15
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
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
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106743256CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-20
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
10197106675250CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-27
10197106665183CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-25