Duns Number:291555621
Device Description: MicroCO
Catalog Number
36-MC02-STK
Brand Name
Micro Medical
Version/Model Number
36-MC02-STK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 22, 2019
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
-
Product Code
CCJ
Product Code Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Public Device Record Key
cdd3ef4c-7845-44c4-bb9e-5bc151af1d06
Public Version Date
May 23, 2019
Public Version Number
3
DI Record Publish Date
July 29, 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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 21 |