Duns Number:145581588
Device Description: DATUM+ SEVO 8% DRAGER KEYFILLER - BLEASE
Catalog Number
13063118
Brand Name
Spacelabs Healthcare
Version/Model Number
DATUM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 12, 2019
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"
Yes
For Single-Use
-
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
K942799
Product Code
CAD
Product Code Name
VAPORIZER, ANESTHESIA, NON-HEATED
Public Device Record Key
1e446fdc-35b3-42d0-b154-8f09c2b86707
Public Version Date
July 12, 2019
Public Version Number
5
DI Record Publish Date
December 29, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 732 |