FDA.report

maxill Plus Earloop Style Procedural Masks, Classic, Blue

Primary DI
00060705530516
Brand
maxill Plus Earloop Style Procedural Masks, Classic, Blue
Company
MAXILL, INC.
Model
53051
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FXXMask, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00060705530516PrimaryGS10
90060705530519Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00060705530516000607055305160607055305160060705530516
9006070553051990060705530519

GMDN Terms

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

Regulatory Flags

DUNS number
079343581
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true
Sterilization required before use
false

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D89260705601812PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601812024-01-12
D89260705601822PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601822024-01-12
D89260705601832PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601832024-01-12
D89260705601842PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601842024-01-12
D89260705601852PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601852024-01-12
D89260705601862PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601862024-01-12
D89260705601872PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601872024-01-12
D8926070553277D11maxill Frames Eyewear Adult6070553277D12022-11-15
D89260705532601maxill Frames Eyewear60705532602022-11-14
D89260705532631maxill Frames Eyewear60705532632022-11-14
D8926070553265D21maxill Frames Eyewear Kids6070553265D22022-11-14
D8926070553265D31maxill Frames Eyewear Kids6070553265D32022-11-14
D8926070553275C01maxill Frames Eyewear Adult6070553275C02022-11-14
D8926070553275C11maxill Frames Eyewear Adult6070553275C12022-11-14
D8926070553275C21maxill Frames Eyewear Adult6070553275C22022-11-14
D8926070553275C31maxill Frames Eyewear Adult6070553275C32022-11-14
D8926070553275C91maxill Frames Eyewear Adult6070553275C92022-11-14
D8926070553276C01maxill Frames Eyewear Adult6070553276C02022-11-14
D8926070553276C11maxill Frames Eyewear Adult6070553276C12022-11-14

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