Duns Number:062084215
Device Description: MIXER,3500,POLE MNT,SPANISH
Catalog Number
-
Brand Name
Sechrist Industries, Inc.
Version/Model Number
20459-1
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
K992503
Product Code
BZR
Product Code Name
Mixer, Breathing Gases, Anesthesia Inhalation
Public Device Record Key
e56930e3-5bf6-463f-bef1-441d05097850
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 12, 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. | 169 |