Duns Number:002348191
Device Description: ARROW(R) Midline with Chlorag+ard(R) Technology
Catalog Number
CDC-41541-MPK1A
Brand Name
ARROW
Version/Model Number
IPN037697
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161313,K161313
Product Code
PND
Product Code Name
Midline catheter
Public Device Record Key
6ac81810-2b6d-4336-9a4b-526179c1e08c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 30, 2017
Package DI Number
20801902130154
Quantity per Package
5
Contains DI Package
10801902130157
Package Discontinue Date
September 05, 2017
Package Status
Not 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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |