SENSITHERM MULTI ST-ADPT-30

GUDID 08058480754618

The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be inserted in a dedicated socket on the handle of the ST-PTCBL patient cable for connecting the conductive terminals of ST -Probe to a mapping system. At one end, the adapter cable is equipped with a custom plug compatible with the dedicated port in the patient cable. The other end of the cable contains seven single pole polyurethane cables, each one ending in a 2mm touch-proof plug compatible with the input ports of a mapping system.

FIAB SPA

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

Primary Device ID	08058480754618
NIH Device Record Key	0fb49c55-6836-4b48-b9d2-8c2ac2987bbc
Commercial Distribution Status	In Commercial Distribution
Brand Name	SENSITHERM MULTI
Version Model Number	ST-ADPT-30
Catalog Number	ST-ADPT-30
Company DUNS	439770017
Company Name	FIAB SPA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it
Phone	+39 0558497943
Email	quality@fiab.it

Operating and Storage Conditions

Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08058480754618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192210

FDA Product Code

IKD	Cable, Electrode

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-02-14
Device Publish Date	2022-02-04

On-Brand Devices [SENSITHERM MULTI]

08058480754700	The patient cable, ST-PTCBL is the component of SENSITHERM MULTI System which connects the main
08058480754618	The ST-ADPT-30 adapter cable is an accessory for the SENSITHERM MULTI system that can be ins
18058480753991	ST-PROBE-7 is an esophageal lead made of an external isolating cover in medical polyurethane wi
18058480753984	ST-PROBE-5 is an esophageal lead made of an external isolating cover in medical polyurethane wit