Pasture F550G Respirator

Primary DI
B624F550G30
Brand
Pasture F550G Respirator
Company
PASTURE PHARMA PTE LTD
Model
F550G
Device description
This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies.
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
NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZJRespirator, N95, For Use By The General Public In Public Health Medical EmergenciesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083176000PASTURE, MODELS: F550, A520Pasture Pharma Pte, Ltd.2009-01-23NZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B624F550G30PrimaryHIBCC0
B624F550G0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Public respirator, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
628369480
Device count
3
Lot or batch
true
Expiration 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
B624F550S200Pasture F550S RespiratorF550S2018-01-03
B62460S300Pasture 60S Mask60S2018-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094573065CuraplexBOUND TREE MEDICAL, LLCNZJ2022-03-31
00812277033892CuraplexBOUND TREE MEDICAL, LLCNZJ2018-12-15
00812277033908CuraplexBOUND TREE MEDICAL, LLCNZJ2018-12-15
00812277033915CuraplexBOUND TREE MEDICAL, LLCNZJ2018-12-15
00812277033922CuraplexBOUND TREE MEDICAL, LLCNZJ2018-12-15
00812277033939CuraplexBOUND TREE MEDICAL, LLCNZJ2018-12-15
B624A520G200Pasture A520G RespiratorPASTURE PHARMA PTE LTDNZJ2018-01-03
B624F550G200Pasture F550G RespiratorPASTURE PHARMA PTE LTDNZJ2018-01-03