Duns Number:439770017
Device Description: ESOTEST ULTRA interconnect cable is intended to connect Monitor (ESOTEST ULTRA 30112 model ESOTEST ULTRA interconnect cable is intended to connect Monitor (ESOTEST ULTRA 30112 model number) to probe (ESOTEST PROBE 26155S/US model number). ESOTEST System is intended for continue esophageal temperature monitoring and it consists of 3 components: monitor, interconnect cable and probe.
Catalog Number
F5406/ULTRA
Brand Name
ESOTEST INTERCONNECT CABLE
Version/Model Number
F5406/ULTRA
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
-
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
K123361
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
f89321c1-68c3-40d3-a1f2-607ea0b56271
Public Version Date
January 09, 2020
Public Version Number
2
DI Record Publish Date
December 06, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |