Duns Number:458942687
Device Description: Key Filler Bottle Adaptor for use with Isoflurane, Halothane & Sevoflurane in an MRI Envir Key Filler Bottle Adaptor for use with Isoflurane, Halothane & Sevoflurane in an MRI Environment
Catalog Number
-
Brand Name
Key Filler Bottle Adaptor MRI
Version/Model Number
Key Filler Bottle Adaptor MRI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053564
Product Code
CAD
Product Code Name
Vaporizer, Anesthesia, Non-Heated
Public Device Record Key
ffde5559-e61d-4b55-ac3c-4a630036ab63
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 01, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |