Duns Number:006261481
Device Description: HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK
Catalog Number
-
Brand Name
MYOtherm XP™
Version/Model Number
CBXP41B
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
K003724,K003724
Product Code
DTR
Product Code Name
HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
Public Device Record Key
7e3f8528-93f7-42c5-8ef1-5a970ad4dd19
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
January 21, 2017
Package DI Number
20643169766932
Quantity per Package
4
Contains DI Package
00643169766921
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |