Duns Number:058027475
Device Description: Non-Vented Administration Set with Chamber Pump, 2 Gang Stopcocks, 2 Needlefree Valves & S Non-Vented Administration Set with Chamber Pump, 2 Gang Stopcocks, 2 Needlefree Valves & Spinlock
Catalog Number
-
Brand Name
Codan
Version/Model Number
W22199-W
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
6bc298ba-430e-42e0-bd69-5c05e06a5408
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 28, 2016
Package DI Number
813153021385
Quantity per Package
1
Contains DI Package
10813153021382
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 381 |