Duns Number:662213220
Device Description: SMARTez 250-250-60m
Catalog Number
-
Brand Name
SMARTeZ Pump
Version/Model Number
481056
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
K151650,K151650,K151650
Product Code
MEB
Product Code Name
Pump, Infusion, Elastomeric
Public Device Record Key
2e01a151-4f8b-444b-bb2a-f31fe4005ebf
Public Version Date
December 07, 2020
Public Version Number
1
DI Record Publish Date
November 27, 2020
Package DI Number
98859299101050
Quantity per Package
48
Contains DI Package
68859299101059
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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 39 |