Duns Number:006261481
Device Description: HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK
Catalog Number
-
Brand Name
CB MYOtherm XP®
Version/Model Number
CBXP41B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2019
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
7d7ceb37-83f6-4013-a3fa-6db1fc6df661
Public Version Date
September 22, 2022
Public Version Number
5
DI Record Publish Date
June 09, 2015
Package DI Number
20613994947790
Quantity per Package
4
Contains DI Package
00613994947796
Package Discontinue Date
October 21, 2019
Package Status
Not 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 |