Duns Number:006261481
Device Description: DISTAL 33100 PERF SET QUICKFLOW 15L
Catalog Number
-
Brand Name
QUICKFLOW DPS™
Version/Model Number
33100
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
K993677,K993677
Product Code
DWF
Product Code Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Public Device Record Key
b949edf4-61bc-4a61-8451-53a0be0302bd
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
June 13, 2016
Package DI Number
20885074257109
Quantity per Package
5
Contains DI Package
00885074257105
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |