Duns Number:058716649
Device Description: Intego Source Admin Set (SAS)(Intego - Source Administration Set)(60766884)
Catalog Number
INT CSS
Brand Name
MEDRAD® Intego Sterile Disposables
Version/Model Number
INT CSS
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
-
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
K080297,K080297
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
e99fd670-3d23-4f2c-ab5e-42bd9477255a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10616258005291
Quantity per Package
20
Contains DI Package
00616258005294
Package Discontinue Date
December 31, 9999
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |