Duns Number:002348191
Device Description: TheraCath(R) Epidural Catheterization Kit
Catalog Number
MM-05001
Brand Name
ARROW
Version/Model Number
IPN046484
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103658,K103658
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
dac870ae-c605-4546-9702-c0f5b5b602cd
Public Version Date
July 27, 2022
Public Version Number
6
DI Record Publish Date
November 07, 2018
Package DI Number
50801902012048
Quantity per Package
10
Contains DI Package
40801902012041
Package Discontinue Date
July 22, 2022
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |