Duns Number:504406273
Catalog Number
-
Brand Name
CAPNOGRAPHY CONNECTOR W/10FT LINE + MALE LUER FILTER
Version/Model Number
010-750U
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133516
Product Code
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
de34fedd-50a2-42c7-a5e5-efa0dd38b9b7
Public Version Date
August 05, 2022
Public Version Number
5
DI Record Publish Date
October 04, 2016
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 | 715 |
2 | A medical device with a moderate to high risk that requires special controls. | 465 |