Medical Face Mask

Primary DI
04007418891158
Brand
Medical Face Mask
Company
Hans Hepp GmbH & Co. KG
Model
89115
Device description
A 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.
Published
2023-07-28
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04007418891158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04007418891158040074188911584007418891158

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
315896217
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04007418924016Disposable Gloves Size L924012023-08-11
04007418924023Disposable Gloves Size L924022023-08-11
04007418924511Disposable Gloves Size L924012023-08-11
04007418924528Disposable Gloves Size L924022023-08-11
04007418891141Medical Face Mask891142023-07-28
04007418914857Plaster Assortment914852023-07-25
04007418920704Wound Compresses 100mm x 100mm920702023-07-25
04007418920735Wound Compresses 100mm x 100mm920732023-07-25
04007418921404Triangular Bandage 96cm x 96cm x 136cm921402023-07-25
04007418921459Triangular Bandage 96cm x 96cm x 136cm921452023-07-25
04007418921732Elastic Bandage 6cm x 4m921732023-07-25
04007418921831Elastic Bandage 8cm x 4m921832023-07-25
04007418922005First Aid Dressing G Compress 10cm x 12cm922002023-07-25
04007418922036First Aid Dressing G Compress 10cm x 12cm922032023-07-25
04007418922104First Aid Dressing M Compress 8cm x 10cm922102023-07-25
04007418922203First Aid Dressing K Compress 6cm x 8cm922202023-07-25
04007418922234First Aid Dressing K Compress 6cm x 8cm922232023-07-25
04007418922531Bandaging Cloth A 600mm x 800mm922532023-07-25
04007418922555Bandaging Cloth A 600mm x 800mm922552023-07-25
04007418932806Adhesive Tape 5m x 2,5cm932802023-07-25

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