Duns Number:058614483
Device Description: Tumescent Pump Tubing Set,4 m
Catalog Number
TTUB-4
Brand Name
ClosureFast
Version/Model Number
TTUB-4
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071588,K071588,K071588
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
58724f11-5b53-4e1d-97fd-1038c64c1798
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 13, 2016
Package DI Number
30884521140442
Quantity per Package
160
Contains DI Package
10884521140448
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |