Duns Number:055363428
Device Description: X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD/W INTERP, PACING, NIBP, SPO2, CPR EXPANS X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD/W INTERP, PACING, NIBP, SPO2, CPR EXPANSION PACKE AND ETCO2, DMSTC, REFURB
Catalog Number
-
Brand Name
X SERIES
Version/Model Number
631-2221111-01
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
K102174
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
56bb6c9b-189e-4b23-93a9-c792d2d88e09
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |