Duns Number:622637544
Device Description: Fluid Delivery Set
Catalog Number
CIV-032
Brand Name
CIV
Version/Model Number
CIV-032
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 06, 2020
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
K935642,K935642
Product Code
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
ce46c6b4-428b-4f1b-a153-0bc46663b836
Public Version Date
April 07, 2021
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |