Duns Number:228480810
Device Description: Capnomask™ Ophthalmic oxygen mask + CO2 sampling line 300cm with male/female connector + O Capnomask™ Ophthalmic oxygen mask + CO2 sampling line 300cm with male/female connector + O2 tube 200cm
Catalog Number
-
Brand Name
Mediplus
Version/Model Number
A202CFX
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
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
K131339,K131339
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
f8a5e3a9-7947-4b3b-8cc5-b7b38e116f37
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 05, 2018
Package DI Number
15055140703856
Quantity per Package
50
Contains DI Package
05055140703859
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |