Duns Number:120818216
Device Description: FILTER AND FLUID CONNECTOR KIT
Catalog Number
MSPT-010878
Brand Name
MEDICAL SPECIALTIES
Version/Model Number
MSPT-010878
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"
-
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
OJA
Product Code Name
Intravenous extension tubing set
Public Device Record Key
d1e3f2dd-223d-4c48-a187-3f0e5786c498
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
38498840006871
Quantity per Package
50
Contains DI Package
08498840006870
Package Discontinue Date
-
Package Status
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 | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 833 |