Duns Number:305682023
Device Description: Compression Unit Upto 650ml, stand alone, complementary accessory (to be used with ACTion Compression Unit Upto 650ml, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Catalog Number
-
Brand Name
Compression Unit Set, 650ml, with Clamp
Version/Model Number
418000650
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
85d239e3-c190-4df2-8570-30da61e96d40
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 19, 2017
Package DI Number
05707480121793
Quantity per Package
8
Contains DI Package
05707480121755
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 |