Duns Number:021063219
Device Description: Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with p Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring
Catalog Number
A-WSS-001-ZA
Brand Name
NK-HealthProtect Wireless Surge Solution
Version/Model Number
A-WSS-001-ZA
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRG
Product Code Name
TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Public Device Record Key
6f4ef476-7ddb-42d7-8321-b1cac31e518c
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
May 01, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 393 |