Duns Number:938289980
Device Description: A collection of sterile devices including tubing and typically clamps, filters, connectors A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
Catalog Number
H-7556
Brand Name
E. MAINE MEM. ADAPTER PK. - ME. EXTRACORPOREAL TUBE PACK
Version/Model Number
H-7556
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTM
Product Code Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Public Device Record Key
e202ecbf-fca3-4e47-8297-212f8bfeba7c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 09, 2015
Package DI Number
B066H75563
Quantity per Package
20
Contains DI Package
B066H75560
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. | 50 |