Duns Number:079375431
Device Description: HYH,EP TRY,S-SHOT,-,-,10
Catalog Number
182293
Brand Name
Halyard
Version/Model Number
93483
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K941153,K941153
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
ddc8d31e-e669-45a5-91d9-b38c9d1e3a5f
Public Version Date
November 08, 2019
Public Version Number
6
DI Record Publish Date
May 25, 2016
Package DI Number
30680651934834
Quantity per Package
10
Contains DI Package
10680651934830
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |