Duns Number:009527042
Device Description: Anesthesia Workstation with standard features only: English Language. Europe Power Setup
Catalog Number
0081508502014
Brand Name
A9800 Anesthesia Workstation
Version/Model Number
A9800
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131790
Product Code
BSZ
Product Code Name
Gas-Machine, Anesthesia
Public Device Record Key
06f6d3c6-ef5c-445c-b208-a87f89d1f440
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 25, 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. | 44 |