FDA.reportPublic FDA data

AMXOR Imperative 3-Layers SMS Jacket

Primary DI
00850049248129
Brand
AMXOR Imperative 3-Layers SMS Jacket
Company
Amxor Healthcare LLC
Model
AJ-CBS
Device description
AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Small, Ceil Blue
Published
2024-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
00850049248129PackageGS110In Commercial Distribution
10850049248126PackageGS15In Commercial Distribution
00850049248112PrimaryGS10
10850049248119Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049248129008500492481298500492481290850049248129
1085004924812610850049248126
00850049248112008500492481128500492481120850049248112
1085004924811910850049248119

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124112849
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00850049248075AMXOR Imperative 3-Layer SMS JacketAJ-PKS2024-03-13
00850049248099AMXOR Imperative 3-Layer SMS JacketAJ-PPS2024-03-13
00850049248112AMXOR Imperative 3-Layers SMS JacketAJ-CBS2024-03-13
00850049248136AMXOR Imperative 3-Layer SMS JacketAJ-PKM2024-03-13
00850049248150AMXOR Imperative 3-Layer SMS JacketAJ-PPM2024-03-13
00850049248174AMXOR Imperative 3-Layer SMS JacketAJ-CBM2024-03-13
00850049248198AMXOR Imperative 3-Layer SMS JacketAJ-PKL2024-03-13
00850049248211AMXOR Imperative 3-Layer SMS JacketAJ-PPL2024-03-13
00850049248235AMXOR Imperative 3-Layer SMS JacketAJ-CBL2024-03-13
00850049248259AMXOR Imperative 3-Layer SMS JacketAJ-PKXL2024-03-13
00850049248273AMXOR Imperative 3-Layer SMS JacketAJ-PPXL2024-03-13
00850049248297AMXOR Imperative 3-Layer SMS JacketAJ-CBXL2024-03-13
00850049248082AMXOR Imperative 3-Layer SMS JacketAJ-PKS2024-03-13
00850049248105AMXOR Imperative 3-Layer SMS JacketAJ-PPS2024-03-13
00850049248143AMXOR Imperative 3-Layer SMS JacketAJ-PKM2024-03-13
00850049248167AMXOR Imperative 3-Layer SMS JacketAJ-PPM2024-03-13
00850049248181AMXOR Imperative 3-Layer SMS JacketAJ-CBM2024-03-13
00850049248204AMXOR Imperative 3-Layer SMS JacketAJ-PKL2024-03-13
00850049248228AMXOR Imperative 3-Layer SMS JacketAJ-PPL2024-03-13
00850049248242AMXOR Imperative 3-Layer SMS JacketAJ-CBL2024-03-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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