FDA.reportPublic FDA data

Isolation Gown - Yellow

Primary DI
00850015055072
Brand
Isolation Gown - Yellow
Company
ULINE, INC.
Model
S-24019Y
Published
2020-12-08
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 Isolation Gown

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850015055079PrimaryGS10
00850015055072Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001505507910850015055079
00850015055072008500150550728500150550720850015055072

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039612668
Device count
50
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850015055826Trauma KitH-99542026-04-06
10851253007691Uline Burn Kit - Single UseH-4172H-41722019-01-18
10850015055789ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, LARGES-12549L2025-04-28
10850015055796ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, MEDIUMS-12549M2025-04-28
10850015055802ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, SMALLS-12549S2025-04-28
10850015055819ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XLS-12549X2025-04-28
30850015055561ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, LARGES-12549L2025-04-28
30850015055578ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, MEDIUMS-12549M2025-04-28
30850015055585ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, SMALLS-12549S2025-04-28
30850015055592ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XLS-12549X2025-04-28
10850015055307Uline 25 Person First Aid Kit - SUBH-1293-S12022-01-14
10850015055314Uline 50 Person First Aid Kit - SUBH-1294-S12022-01-14
10850015055727ULINE REUSABLE EARPLUGS - UNCORDEDS-198732024-07-25
10850015055734ULINE REUSABLE EARPLUGS - CORDEDS-198742024-07-25
30850015055509ULINE REUSABLE EARPLUGS - UNCORDEDS-198732024-07-25
30850015055516ULINE REUSABLE EARPLUGS - CORDEDS-198742024-07-25
10850015055741ULINE BULLET EARPLUGS - UNCORDEDS-179022024-07-23
10850015055758ULINE BULLET EARPLUGS - CORDEDS-179032024-07-23
10850015055765ULINE BELL EARPLUGS - UNCORDEDS-221402024-07-23
10850015055772ULINE BELL EARPLUGS - CORDEDS-221412024-07-23

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