Duns Number:480868538
Device Description: The TEMPUS LS – MANUAL is a multi-function, portable device that is capable of providing d The TEMPUS LS – MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings.
Catalog Number
00-3020
Brand Name
Tempus LS-MANUAL
Version/Model Number
3.940589
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
K200849
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
4e340db2-db5a-4a47-ba9d-36ce8f291242
Public Version Date
September 11, 2020
Public Version Number
2
DI Record Publish Date
August 11, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |