FDA.reportPublic FDA data

AMXOR Imperative 3-Layer SMS Jacket

Primary DI
00850049248150
Brand
AMXOR Imperative 3-Layer SMS Jacket
Company
Amxor Healthcare LLC
Model
AJ-PPM
Device description
AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Medium, Purple
Published
2024-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00850049248167PackageGS110In Commercial Distribution
10850049248164PackageGS15In Commercial Distribution
00850049248150PrimaryGS10
10850049248157Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049248167008500492481678500492481670850049248167
1085004924816410850049248164
00850049248150008500492481508500492481500850049248150
1085004924815710850049248157

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.

Contacts#

Phone, Email table
PhoneEmail
7867861207e.colon@amxorhealthcare.com

Regulatory Flags#

DUNS number
124112849
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
00850049248129AMXOR Imperative 3-Layers SMS JacketAJ-CBS2024-03-13
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
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