Duns Number:005083209
Device Description: The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets.
Catalog Number
955516
Brand Name
therMaxTherMax Blood Warmer
Version/Model Number
955516
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"
Yes
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
K190910,K190910
Product Code
KDI
Product Code Name
Dialyzer, high permeability with or without sealed dialysate system
Public Device Record Key
683ee3b2-ec4a-4b3a-8c46-cdb28e1348b6
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
January 31, 2020
Package DI Number
37332414123933
Quantity per Package
24
Contains DI Package
07332414123932
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |