Duns Number:544313588
Device Description: Rocket DIsposable Bellows Set
Catalog Number
R53902
Brand Name
Rocket
Version/Model Number
R53902
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
Yes
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
-
Product Code Name
-
Public Device Record Key
d7964b5a-fa9a-4d68-ab3a-b619e69f9dd9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 03, 2017
Package DI Number
05055270970411
Quantity per Package
10
Contains DI Package
05055270970404
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |