Duns Number:002348191
Device Description: JEHLE Catheter 4-HEAD STERILE 5 per Box
Catalog Number
351490
Brand Name
PILLING
Version/Model Number
IPN916137
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
-
Product Code
KRA
Product Code Name
Catheter, continuous flush
Public Device Record Key
91c5a57f-d104-4e58-9a6d-feec5bbf1b75
Public Version Date
January 18, 2021
Public Version Number
2
DI Record Publish Date
June 19, 2020
Package DI Number
34026704734291
Quantity per Package
12
Contains DI Package
24026704734294
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tray
| 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 |