Duns Number:806251398
Device Description: IV Administration Set w/Flow Control
Catalog Number
-
Brand Name
IV Administration Set
Version/Model Number
HLSV425562
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
030e69be-8e90-4002-8fb3-df95c2b71bcd
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
March 15, 2017
Package DI Number
20876604001675
Quantity per Package
4
Contains DI Package
10876604001678
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 64 |