Duns Number:316153865
Device Description: Flow-/bubble sensor for 3/8“ x 3/32“ tubing, length 0.9 m. This bubble sensor is an access Flow-/bubble sensor for 3/8“ x 3/32“ tubing, length 0.9 m. This bubble sensor is an accessory for CARDIOHELP System as a miniaturized and light medical perfusion system. The general function of the CARDIOHELP System is to drive, to control, to monitor and to protocol the extra corporeal circulation (ECC). The CARDIOHELP System acts as a drive unit for a disposable tubing set including at least pump and oxygenator. This system is designed for inter- and intra-hospital transportation (transportation (limitations may apply for individual disposables).
Catalog Number
70104.8001
Brand Name
MAQUET CARDIOHELP
Version/Model Number
FBS 3/8" x 3/32" L0.9
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
K102726
Product Code
DTQ
Product Code Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Public Device Record Key
96e1f1ed-c828-4e00-ae9d-86e5caed8dcf
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 |