Duns Number:463720681
Device Description: FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) delivery of drug solutions from 6 glass source containers. It is used in pharmacy compounding or for IV fluid transfer to minimize manipulation when working with small volumen source containers. The device is made up of 6 spikes connected in series with flexible tubing segments, each segment with an idividual clamp. The set terminal, for connection to the pharmacy compounding device sets or administration sets (gravity or pump) consists of a spikeable twist-off valve connector.
Catalog Number
-
Brand Name
FLEBOSET
Version/Model Number
MULTIPLE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 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"
-
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
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
177558a4-5972-4fcf-a98b-85a7cc930748
Public Version Date
October 26, 2021
Public Version Number
5
DI Record Publish Date
April 05, 2017
Package DI Number
28426314583521
Quantity per Package
25
Contains DI Package
08426314583527
Package Discontinue Date
January 01, 2021
Package Status
Not 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. | 15 |