Duns Number:101393924
Catalog Number
-
Brand Name
BioCryo Sequential Circulator
Version/Model Number
SC-2004-DL-OTC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
25b2a182-a52e-4425-85b6-42e01bf8bcea
Public Version Date
April 21, 2022
Public Version Number
1
DI Record Publish Date
April 13, 2022
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. | 235 |