Duns Number:178440426
Device Description: DRE 2000 Labeled (MAX-11)
Catalog Number
-
Brand Name
2000 Anesthesia Replacement Oxygen Cell
Version/Model Number
R113P10-002
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
K972992
Product Code
CCL
Product Code Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Public Device Record Key
b6da57dd-190c-4462-a590-c98f6bcd639e
Public Version Date
March 29, 2021
Public Version Number
4
DI Record Publish Date
September 23, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 230 |