Duns Number:439770017
Device Description: ESOTEST MULTI Probe is an esophageal lead made of an external isolating cover in medical p ESOTEST MULTI Probe is an esophageal lead made of an external isolating cover in medical polyurethane with a diameter of 7 French (2.3mm) and a total length of 83 cm (usable length 75 cm) that is used for monitoring the internal temperature of the esophagus. The probe is equipped with 5 steel rounded electrodes. Each electrode contains a thermocouple for the independent detection of the esophageal temperature.
Catalog Number
2615358H/US
Brand Name
ESOTEST MULTI PROBE
Version/Model Number
2615358H/US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K192210,K192210
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
2e6a267f-d871-49d1-908c-1524bffff7e9
Public Version Date
December 12, 2019
Public Version Number
1
DI Record Publish Date
December 04, 2019
Package DI Number
18054953343874
Quantity per Package
1
Contains DI Package
08054953343877
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |