Duns Number:262207287
Device Description: The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 0 The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 03760232460177)
Catalog Number
-
Brand Name
BA-HFVI-V1
Version/Model Number
V1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
2442356b-42db-41aa-8184-9db0fcf64be5
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
January 10, 2019
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. | 4 |