Pasture F550S Respirator

GUDID B624F550S200

It 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.

PASTURE PHARMA PTE LTD

Surgical/medical respirator, single-use
Primary Device IDB624F550S200
NIH Device Record Keya14b9f92-cc92-49bf-acd5-3e11a9a60193
Commercial Distribution StatusIn Commercial Distribution
Brand NamePasture F550S Respirator
Version Model NumberF550S
Company DUNS628369480
Company NamePASTURE PHARMA PTE LTD
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB624F550S0 [Unit of Use]
HIBCCB624F550S200 [Primary]

FDA Product Code

MSHRespirator,Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2018-01-03

Devices Manufactured by PASTURE PHARMA PTE LTD

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B624A520S200 - Pasture A520S Respirator2020-05-06 It is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personne
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