Duns Number:009251992
Device Description: LIFEPAK SDK COMPATIBLE WITH CODE-STAT V10.1
Catalog Number
21340-000841
Brand Name
Code-Stat Version 10.1
Version/Model Number
21340
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUG
Product Code Name
Medical device data system
Public Device Record Key
05ed1e74-282e-4a53-be2a-bd14b1fadd78
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
February 01, 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 | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |
3 | A medical device with high risk that requires premarket approval | 588 |