Duns Number:461437429
Device Description: Rate Flow® Regulator ADDitIV® IV Set with Universal Spike with 15 ìm filter, Backcheck Val Rate Flow® Regulator ADDitIV® IV Set with Universal Spike with 15 ìm filter, Backcheck Valve, two SafeLine® Injection Sites, On/Off Clamp, Rate Flow Regulator and Spin-Lock® Connector
Catalog Number
-
Brand Name
Rate Flow®
Version/Model Number
L2590263-NF5932
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
K851058,K851058
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
855faa4d-fdec-4a50-934c-b376e4fc979e
Public Version Date
June 05, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
18436020767323
Quantity per Package
50
Contains DI Package
08436020767326
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |