Duns Number:101533727
Device Description: V2.2.0 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
Catalog Number
-
Brand Name
Codonics SLS500i Operating Software
Version/Model Number
2.2.0
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
-
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
K101439
Product Code
BSZ
Product Code Name
Gas-Machine, Anesthesia
Public Device Record Key
b959a4cd-c91c-48fb-8fb1-7042ef2b44d7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |