Duns Number:533108028
Catalog Number
17000-020-0008
Brand Name
Multi-Pump Mounting System kit single pack for US
Version/Model Number
17000-020-0008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 03, 2017
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
K123049,K123049,K123049
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
1cc92aea-f977-487a-9d4f-283a756c9edd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
27290109150097
Quantity per Package
4
Contains DI Package
17290109150090
Package Discontinue Date
March 03, 2017
Package Status
Not in Commercial Distribution
Package Type
cardboard box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |