Duns Number:668172323
Device Description: Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate matter.
Catalog Number
FP3FNWH
Brand Name
SKYPRO
Version/Model Number
SP01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2050
Issuing Agency
In GS1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152197,K152197,K152197
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
d23c8289-86dc-41f3-8031-5073b143de7a
Public Version Date
January 17, 2022
Public Version Number
3
DI Record Publish Date
July 22, 2021
Package DI Number
04897030530982
Quantity per Package
40
Contains DI Package
04897030530975
Package Discontinue Date
January 01, 2050
Package Status
In Commercial Distribution
Package Type
Carton