Duns Number:145581588
Device Description: ABSORBER, BYPASS, 2KG (RE-ROUTE) MRI
Catalog Number
12200904
Brand Name
Spacelabs Healthcare
Version/Model Number
Absorber
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
BSZ
Product Code Name
Gas-machine, anesthesia
Public Device Record Key
0b2fe7a5-4dd0-4357-b579-e4d5d726410e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 29, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 732 |