Duns Number:025460908
Device Description: TEMPERATURE PROBE 9FR W/400 SERIES TEMP
Catalog Number
DYNJAER4009
Brand Name
Medline
Version/Model Number
DYNJAER4009
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
-
Product Code
BZT
Product Code Name
STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
Public Device Record Key
e6790288-1ad3-48a9-9ae2-c8eb37691996
Public Version Date
January 25, 2021
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
30080196551709
Quantity per Package
35
Contains DI Package
10080196551705
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |