Duns Number:025460908
Device Description: TYMPANIC TEMP SENSOR W/400 SERIES THERMI
Catalog Number
DYNJAA400TY
Brand Name
Medline
Version/Model Number
DYNJAA400TY
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
2b5db3c0-e3d3-4b5a-bcd3-ea4952683b63
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
30080196551600
Quantity per Package
50
Contains DI Package
10080196551606
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 |