Duns Number:090508636
Device Description: Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flowmeters; 1 Kit Includes: 6 each VAR Model PCM-5011, 4 each VAR Monitors; 4 each Oxygen Flowmeters; 1 each Multi-outlet manifold; 1 each 20' Heavy Duty Oxygen Hose; 1 each Watertight Carrying Case; 10 each HME Filters
Catalog Number
ES-4070
Brand Name
E-Surge Kit
Version/Model Number
ES-4070
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
-
Product Code Name
-
Public Device Record Key
c26148bb-a013-49b1-b339-a8f95cd95895
Public Version Date
June 12, 2018
Public Version Number
3
DI Record Publish Date
July 14, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |