Duns Number:092673953
Device Description: MR Patient Care Adult LoFLo CO2 with O2 Cannulas (100)
Catalog Number
-
Brand Name
MR Patient Care Adult LoFLo CO2 with O2 Cannulas (100)
Version/Model Number
P185361
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
cf101715-773f-4983-8751-c2700c1f0f25
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
June 30, 2021
Package DI Number
10709078012751
Quantity per Package
100
Contains DI Package
00709078012754
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 746 |
2 | A medical device with a moderate to high risk that requires special controls. | 320 |