Duns Number:106712748
Catalog Number
-
Brand Name
Portex
Version/Model Number
24-2224-01
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
K965017,K965017
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
6484673d-cdf3-4114-8e02-134d70972fa3
Public Version Date
March 17, 2020
Public Version Number
1
DI Record Publish Date
March 09, 2020
Package DI Number
35019517086151
Quantity per Package
10
Contains DI Package
15019517086157
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |