Duns Number:305682023
Device Description: Regulating Set 5-15 + Y tubing Set, stand alone, complementary accessory (to be used with Regulating Set 5-15 + Y tubing Set, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Catalog Number
-
Brand Name
SmartInfuser Set, 5-15ml/hr + Y-Tubing Set
Version/Model Number
418000501
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061409,K061409
Product Code
MEB
Product Code Name
Pump, Infusion, Elastomeric
Public Device Record Key
c9d856d4-3239-46bd-b19e-abfdab39228c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 19, 2017
Package DI Number
05707480119073
Quantity per Package
8
Contains DI Package
05707480119066
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |