AccessGUDID - DEVICE: ESOTEST INTERCONNECT CABLE (08054242448061)

GUDID

Device Identifier (DI) Information

Brand Name: ESOTEST INTERCONNECT CABLE
Version or Model: F5406/ULTRA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F5406/ULTRA
Company Name: FIAB SPA

Primary DI Number: 08054242448061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439770017 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123361	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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