Duns Number:463720681
Device Description: Gri-fill Peristaltic Set is an IV fluid transfer set to be used in conjunction with the Gr Gri-fill Peristaltic Set is an IV fluid transfer set to be used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one source substance is channeled repeatedly to an IV container. It consists of a silicone tube linking a male luer-lock connector and a spike (with a 0.2 µm hydrophobic air filter), and a female luer-lock connection.
Catalog Number
-
Brand Name
GRI-FILL PERISTALTIC 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
K162216,K162216
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
4025e098-0de7-45b7-878a-7b2c2d9e9dfd
Public Version Date
December 24, 2018
Public Version Number
1
DI Record Publish Date
November 21, 2018
Package DI Number
28426314387976
Quantity per Package
25
Contains DI Package
08426314387972
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 |