Duns Number:145581588
Device Description: KIT,DUAL ANT,ACTV,W/O PS,UHF,HI LVL,ROHS
Catalog Number
040-0388-02
Brand Name
Spacelabs Healthcare
Version/Model Number
96280
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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
K141156
Product Code
DSI
Product Code Name
DETECTOR AND ALARM, ARRHYTHMIA
Public Device Record Key
ec3f86d8-f945-4d93-b7f2-7b4b39747ee2
Public Version Date
July 31, 2019
Public Version Number
5
DI Record Publish Date
May 09, 2018
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 732 |