FDA.reportPublic FDA data

AMXOR Essentials Disposable Exam Table Paper Roll

Primary DI
00850049248006
Brand
AMXOR Essentials Disposable Exam Table Paper Roll
Company
Amxor Healthcare LLC
Model
AE-SETP-21
Device description
AMXOR Essentials Disposable Exam Table Paper Roll, Smooth Finish, White Color, Sleeve Package
Published
2024-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850049248003PackageGS112In Commercial Distribution
00850049248006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004924800310850049248003
00850049248006008500492480068500492480060850049248006

GMDN Terms#

Term, Definition table
TermDefinition
Basic bed sheet, single-useA large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Contacts#

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

Regulatory Flags#

DUNS number
124112849
Device count
1
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
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
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

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Primary DI, Brand, Company table
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