Duns Number:367919120
Device Description: Vital Signs® Disposable Esophageal Stethoscope with Temperature Probe, Non-Sterile, Vital Signs® Disposable Esophageal Stethoscope with Temperature Probe, Non-Sterile, 9FR
Catalog Number
1013EU
Brand Name
Vital Signs
Version/Model Number
1013EU
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
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
d79b48fd-273f-4dcd-bbd0-8bc049449d90
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 26, 2016
Package DI Number
50885403288300
Quantity per Package
50
Contains DI Package
10885403288302
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 363 |