Duns Number:145581588
Device Description: CO2 AIRWAY ADAPTER, PEDIATRIC/ADULT
Catalog Number
704-0023
Brand Name
SPACELABS HEALTHCARE
Version/Model Number
91517
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"
Yes
For Single-Use
Yes
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
K031124,K031124
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
b7a8aa8c-e936-423d-9af3-a4ac7671b8b8
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
December 11, 2019
Package DI Number
30841522126370
Quantity per Package
10
Contains DI Package
10841522126376
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
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 |