Duns Number:006261481
Device Description: EXCHANGER 61399400964 12CA HT BIOTHERM
Catalog Number
-
Brand Name
BIOtherm™
Version/Model Number
61399400964
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 2015
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
K884560
Product Code
DTR
Product Code Name
HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
Public Device Record Key
6e66f29a-8b0c-4920-9099-f100e4a2fc3b
Public Version Date
December 11, 2019
Public Version Number
4
DI Record Publish Date
June 09, 2015
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 | 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 |