Duns Number:305524696
Device Description: SpeediCath Flex Set CH12
Catalog Number
28932
Brand Name
SpeediCath Flex Set
Version/Model Number
28932
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
K222059,K222059,K222059
Product Code
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
9b478032-dfbd-4c01-a9c9-194770e88043
Public Version Date
October 17, 2022
Public Version Number
1
DI Record Publish Date
October 09, 2022
Package DI Number
05701780221641
Quantity per Package
3
Contains DI Package
05701780221535
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |