Duns Number:070617139
Device Description: Prime ES Plus
Catalog Number
62338
Brand Name
Stat Profile
Version/Model Number
Prime ES Plus
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
-
Product Code
CHL
Product Code Name
Electrode measurement, blood-gases (pco2, po2) and blood ph
Public Device Record Key
5d38ff55-8f25-4817-a052-b28abd1958bc
Public Version Date
February 11, 2020
Public Version Number
1
DI Record Publish Date
February 03, 2020
Package DI Number
10385480623381
Quantity per Package
1
Contains DI Package
00385480623384
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 165 |
2 | A medical device with a moderate to high risk that requires special controls. | 210 |