Duns Number:002125419
Catalog Number
-
Brand Name
BG 323 Pump
Version/Model Number
PUMP-BG323
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2020
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
baa036dc-06df-4866-b7a8-db98b6cd4cc8
Public Version Date
July 04, 2022
Public Version Number
6
DI Record Publish Date
January 16, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 125 |