Duns Number:093370369
Catalog Number
-
Brand Name
IV Administration Set 60 Drop
Version/Model Number
036106222000
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
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
d16b4178-d74a-42a3-a9d0-ce23874e0413
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
January 01, 2019
Package DI Number
20853620005337
Quantity per Package
4
Contains DI Package
10853620005330
Package Discontinue Date
-
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |