Duns Number:516398679
Device Description: Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Exhaust M Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Exhaust Module (3003-031-005)
Catalog Number
3003-030-UB9
Brand Name
System M ®
Version/Model Number
Gas Management System
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRY
Product Code Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Public Device Record Key
0d194889-3a04-41a3-9417-e06aa71ad148
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 111 |