Duns Number:316153865
Device Description: Air Embolism Protection (AEP) System including a bubble/level monitoring kit. This AEP is Air Embolism Protection (AEP) System including a bubble/level monitoring kit. This AEP is an accessory for The Heart-Lung Machine HL 20 , which is a modular system for regulation, control and monitoring of the extracorporeal circulation. Its purpose is the support and maintenance of the extracorporeal blood circulation and is used during cardiac surgeries.
Catalog Number
70101.0853
Brand Name
Maquet HL-20 System
Version/Model Number
AEP 20-415 Bubble Level Monitoring Kit
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K943803
Product Code
DTQ
Product Code Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Public Device Record Key
3167bc60-6953-4899-a3ea-09d9db6f970d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 13, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |