Duns Number:690543319
Device Description: CAPIOX RED CABLE
Catalog Number
-
Brand Name
CAPIOX RED CABLE
Version/Model Number
CX*BP022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
df4fa203-9903-4e7f-a1db-eb1f6c82e52d
Public Version Date
March 03, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
54987350705674
Quantity per Package
100
Contains DI Package
04987350705679
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |