Duns Number:092673953
Device Description: MR Patient Care Neonatal LoFlo CO2 with Cannulas (20)
Catalog Number
-
Brand Name
MR Patient Care Neonatal LoFlo CO2 with Cannulas (20)
Version/Model Number
P183261
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
7b499cf8-d485-4c82-b3a9-f46830f399e0
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
June 30, 2021
Package DI Number
10709078012706
Quantity per Package
20
Contains DI Package
00709078012709
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 |