Duns Number:002397347
Device Description: IV ADMIN SET W/ 15 DROPS/ML, 126 IN.
Catalog Number
490481
Brand Name
Anesthesia IV Set
Version/Model Number
490481
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 29, 2021
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
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
d5000529-c5d1-47f8-9cf2-d0d6b566a680
Public Version Date
July 30, 2021
Public Version Number
5
DI Record Publish Date
February 09, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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. | 277 |
U | Unclassified | 2 |