Duns Number:153608369
Device Description: PPE PACK CAP/MASK/SHOE COVER/GOWN
Catalog Number
MSPP-020141
Brand Name
MedStream
Version/Model Number
MSPP-020141
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
PXG
Product Code Name
Spill Kit
Public Device Record Key
28fe5ccf-3b8d-46e1-be6f-2bb2d2bdfb89
Public Version Date
December 17, 2018
Public Version Number
2
DI Record Publish Date
September 27, 2018
Package DI Number
10842472106784
Quantity per Package
25
Contains DI Package
00842472106787
Package Discontinue Date
December 14, 2018
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 202 |
2 | A medical device with a moderate to high risk that requires special controls. | 86 |