Duns Number:797372554
Device Description: PUMP SEGMENT 8.0 mm PRIMING VOLUME 152 ML EQUIPMENT FRESENIUS 2008
Catalog Number
BL+A210/V803
Brand Name
NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET
Version/Model Number
A210/V803
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
Yes
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
FJK
Product Code Name
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Public Device Record Key
f3c53763-9fb7-41a8-8ae7-7ac58aef14ce
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2015
Package DI Number
40383790004068
Quantity per Package
24
Contains DI Package
00383790004060
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 230 |