Duns Number:305682023
Device Description: ACTion Block 1000, 5-15 ml/hr (2 reservoirs for 1000 ml)
Catalog Number
419111000
Brand Name
ACTion™ Block Pump, 1000ml, 5-15 ml/hr, Clamp
Version/Model Number
419111000
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
K072053,K072053
Product Code
MEB
Product Code Name
Pump, infusion, elastomeric
Public Device Record Key
cd35c4bf-4c82-4b75-8600-e85aa9e0a6f9
Public Version Date
September 04, 2020
Public Version Number
1
DI Record Publish Date
August 27, 2020
Package DI Number
05707480143856
Quantity per Package
4
Contains DI Package
05707480143849
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 |