Duns Number:006261481
Device Description: CONSOLE R5100052 PERFORMER CPB,UNIV
Catalog Number
-
Brand Name
Performer™
Version/Model Number
R5100052
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052555
Product Code
DTQ
Product Code Name
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Public Device Record Key
11715e3e-2c52-467f-ba5f-4cf6a9824565
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 18, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |