Duns Number:088302096
Catalog Number
54000
Brand Name
Digital 4 Cylinder Stand
Version/Model Number
54000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
September 24, 2199
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
K052335
Product Code
BSZ
Product Code Name
Gas-Machine, Anesthesia
Public Device Record Key
c9be5859-b798-4f14-8ab2-6bd6c5332372
Public Version Date
October 02, 2019
Public Version Number
1
DI Record Publish Date
September 24, 2019
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 | 344 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |