Duns Number:079226216
Device Description: CARTRIDGE, Total B-hCG
Catalog Number
05p58-25
Brand Name
i-STAT
Version/Model Number
05p58-25
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
CHL
Product Code Name
ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
Public Device Record Key
55322f58-51af-4fcf-997f-63ce51f9338d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
Package DI Number
00054749001002
Quantity per Package
25
Contains DI Package
10054749001009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |
| 3 | A medical device with high risk that requires premarket approval | 14 |