Duns Number:463720681
Device Description: FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different via FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances.
Catalog Number
-
Brand Name
FLEBOSET
Version/Model Number
DOUBLE
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"
-
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
K102590,K102590
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
d6fb350b-b710-4102-b16e-931b20b60c3f
Public Version Date
September 22, 2021
Public Version Number
5
DI Record Publish Date
April 05, 2017
Package DI Number
28426314792572
Quantity per Package
35
Contains DI Package
08426314792578
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. | 15 |