FDA.reportPublic FDA data

Procedure Face Masks with Ear Loop, Glass-Free Filter, Blue

Primary DI
00616784220123
Brand
Procedure Face Masks with Ear Loop, Glass-Free Filter, Blue
Company
Dynarex Corporation
Model
2201
Published
2016-09-24
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
K202191000
K202708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202191000Surgical MaskWuhan Zonsen Medical Products Co., Ltd.2021-03-29FXX
K202708000Surgical Face MasksIntco Medical(Hk) Co., Ltd.2021-03-30FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784220130PackageGS112In Commercial Distribution
00616784220123PrimaryGS10
00810180843904Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784220130006167842201306167842201300616784220130
00616784220123006167842201236167842201230616784220123
00810180843904008101808439048101808439040810180843904

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, reprocessedA 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 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 and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a previously used single-use device that has been processed for an additional single-use patient application.

Regulatory Flags#

DUNS number
008124539
Device count
50
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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00840117352162AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67232019-11-25
00840117352186AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67242019-11-25
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,89402018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, Sterile89412018-05-26
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00840117343788Dynacare HerCare Necessities Complete Kit13752026-05-29
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00616784562018DynaLift Transport Unit, White, 40" x 80" (101.6 cm x 203.2 cm)56202021-04-22
00616784562117DynaLift Transport Unit, Black, 40" x 80" (101.6 cm x 203.2 cm)56212021-04-22
00840117308992Resp-O2 Single Suction Catheter, 12 FR320032022-05-10
00840117309012Resp-O2 Single Suction Catheter, 14 FR320042022-05-10
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