FDA.reportPublic FDA data

Azer Scientific

Primary DI
00843792144275
Brand
Azer Scientific
Company
AZER SCIENTIFIC INCORPORATED
Model
1
Catalog number
ES86431
Device description
Face mask, disposable procedure mask, 3-ply with ear loop, 50/box, 40 boxes/case
Published
2020-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123787000GREENCROSS SURGICAL MASKJingzhou Haixin Green Cross Medical Products Co.,L2013-07-17FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843792144275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843792144275008437921442758437921442750843792144275

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; 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) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
137459512
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20859047006001Glucose Tolerance Beverage10-FP-05010-FP-0502018-12-31
20859047006018Glucose Tolerance Beverage10-FP-07510-FP-0752018-12-31
20859047006025Glucose Tolerance Beverage10-FP-10010-FP-1002018-12-31
20859047006032Glucose Tolerance Beverage10-LL-05010-LL-0502018-12-31
20859047006049Glucose Tolerance Beverage10-LL-07510-LL-0752018-12-31
20859047006056Glucose Tolerance Beverage10-LL-10010-LL-1002018-12-31
20859047006063Glucose Tolerance Beverage10-O-05010-O-0502018-12-31
20859047006070Glucose Tolerance Beverage10-O-07510-O-0752018-12-31
20859047006087Glucose Tolerance Beverage10-O-10010-O-1002018-12-31
20859047006094Glucose Tolerance Beverage10-SP-05010-SP-0502018-12-31
20859047006100Glucose Tolerance Beverage10-SP-10010-SP-1002018-12-31

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Primary DI, Brand, Company table
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