Duns Number:065762392
Device Description: IV CATHETER 22G X 1" Blue
Catalog Number
-
Brand Name
Biotronix Healthcare IV Catheters
Version/Model Number
GEP050022
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"
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
K142797,K142797,K142797
Product Code
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
8d08b6d9-5d2b-4b79-9650-59c058d0a0ad
Public Version Date
December 24, 2019
Public Version Number
2
DI Record Publish Date
October 03, 2019
Package DI Number
20858835007930
Quantity per Package
40
Contains DI Package
10858835007933
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |