Duns Number:005083209
Device Description: Solution Transfer Set with DUO-VENT Spike. Large Bore Tubing and Needle Adapter 26
Catalog Number
2C0427
Brand Name
SOLUTION SET
Version/Model Number
2C0427
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
-
Product Code
NEP
Product Code Name
System/device, pharmacy compounding
Public Device Record Key
3107ed77-c8b4-40bd-8333-97e413473c89
Public Version Date
September 24, 2020
Public Version Number
1
DI Record Publish Date
September 16, 2020
Package DI Number
50085412680748
Quantity per Package
48
Contains DI Package
00085412680743
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |