Duns Number:004175550
Device Description: 2 CYL.CART (DUAL REGULATOR) - This is an accessory only; not a medical device
Catalog Number
-
Brand Name
2 CYL.CART (DUAL REGULATOR)
Version/Model Number
2100-2
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
-
Product Code
BZR
Product Code Name
Mixer, Breathing Gases, Anesthesia Inhalation
Public Device Record Key
d5bbd606-418f-4421-9787-391542a7aed3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 30, 2017
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 | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |