Duns Number:080593067
Device Description: PERIPHERAL INTRAVENOUS CATHETER 22G X 1"
Catalog Number
M203
Brand Name
MEDADV
Version/Model Number
M203
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
K070451,K070451
Product Code
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
29281ac9-20ff-4ad6-ac0a-56f4429ada8c
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 11, 2018
Package DI Number
10819667020224
Quantity per Package
100
Contains DI Package
00819667020227
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |