Duns Number:463720681
Device Description: Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunctio Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.
Catalog Number
-
Brand Name
GRI-FILL 6 to1 Set
Version/Model Number
-
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
K093182,K093182
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
88b00d8a-25e1-49bb-9da3-61a084f51a13
Public Version Date
November 02, 2021
Public Version Number
1
DI Record Publish Date
October 25, 2021
Package DI Number
28426314778774
Quantity per Package
25
Contains DI Package
08426314778770
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |