Duns Number:628369480
Device Description: It is indicated to be used by the healthcare personnel during procedures to protect both t 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.
Catalog Number
-
Brand Name
Pasture F550S Respirator
Version/Model Number
F550S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MSH
Product Code Name
Respirator,Surgical
Public Device Record Key
a14b9f92-cc92-49bf-acd5-3e11a9a60193
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
January 03, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-