FDA.reportPublic FDA data

Pasture 60S Mask

Primary DI
B62460S300
Brand
Pasture 60S Mask
Company
PASTURE PHARMA PTE LTD
Model
60S
Device description
Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
Published
2018-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B62460S300PrimaryHIBCC0
B62460S0Unit of UseHIBCC0

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
628369480
Device count
30
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B624A520CS200Pasture A520CS RespiratorA520CS2018-01-03
B624A520G200Pasture A520G RespiratorA520G2018-01-03
B624A520S200Pasture A520S RespiratorA520S2018-01-03
B624E520CS200Pasture E520CS RespiratorE520CS2018-01-03
B624E520S200Pasture E520S RespiratorE520S2018-01-03
B624F550CS200Pasture F550CS RespiratorF550CS2018-01-03
B624F550G200Pasture F550G RespiratorF550G2018-01-03
B624F550G30Pasture F550G RespiratorF550G2018-01-03
B624F550S200Pasture F550S RespiratorF550S2018-01-03

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