Duns Number:001292192
Device Description: CATHETER W/CONN S/SU 20GA CE FOR 3-1/2IN
Catalog Number
400507
Brand Name
BD Perisafe, BD
Version/Model Number
400507
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"
-
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
K850505,K850505,K850505
Product Code
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
e72f25e4-ec51-4c32-9520-f3d3f70bbf4d
Public Version Date
February 07, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
50382904005073
Quantity per Package
5
Contains DI Package
30382904005079
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |