FDA.report

Abena

Primary DI
00810049810207
Brand
Abena
Company
ABENA NORTH AMERICA, INC.
Model
1000020586
Device description
4-ply mask
Published
2020-07-10
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

Related Records

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810049810207PackageGS150In Commercial Distribution
00810049810191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810049810207008100498102078100498102070810049810207
00810049810191008100498101918100498101910810049810191

GMDN Terms

TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
078740398
Device count
1
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 DIBrandModelCatalogPublished
05713571000731Abena10000213152022-08-09
05703538446153Abena10000208642022-08-08
05703538457869Abena19999053542022-08-08
05703538458460Abena19999053752022-08-08
05703538458613Abena19999053762022-08-08
05703538458675Abena19999053782022-08-08
05713571000014Abena10000212792022-08-08
05713571000038Abena10000212802022-08-08
05713571000052Abena10000212812022-08-08
05713571000076Abena10000212822022-08-08
05713571000090Abena10000212832022-08-08
05713571000113Abena10000212842022-08-08
05713571000137Abena10000212852022-08-08
05713571000151Abena10000212862022-08-08
05713571000175Abena10000212872022-08-08
05713571000199Abena10000212882022-08-08
05713571000212Abena10000212892022-08-08
05713571000236Abena10000212902022-08-08
05713571000250Abena10000212912022-08-08
05713571000274Abena10000212922022-08-08

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