Duns Number:097462979
Device Description: Myocardial temperature probe, 15mm needle, 8' length, 1/8" Plug
Catalog Number
8510
Brand Name
Eight Medical
Version/Model Number
8510
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
-
Product Code
KRI
Product Code Name
Accessory Equipment, Cardiopulmonary Bypass
Public Device Record Key
e1d141e9-f8e0-4f73-8846-79d6245b26e2
Public Version Date
September 21, 2022
Public Version Number
5
DI Record Publish Date
February 20, 2018
Package DI Number
00817278012587
Quantity per Package
25
Contains DI Package
00817278012570
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |