Duns Number:141732011
Device Description: Coda Eco 1200/1500/+Press. Initial/Annual kit
Catalog Number
CPPA-001
Brand Name
Coda®
Version/Model Number
CPPA-001
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
K001486
Product Code
MQG
Product Code Name
ACCESSORY, ASSISTED REPRODUCTION
Public Device Record Key
90226323-45f9-485f-aa6a-2c7f6d54e6f7
Public Version Date
February 06, 2020
Public Version Number
4
DI Record Publish Date
September 28, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 155 |