FDA UDI
In Commercial Distribution
🇺🇸 United States
SENSITHERM MULTI
DI: 08058480754618
·
Model: ST-ADPT-30
·
FIAB SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SENSITHERM MULTI
- Primary DI
- 08058480754618
- Version / Model
- ST-ADPT-30
- Catalog Number
- ST-ADPT-30
- Company Name
- FIAB SPA
- Labeler DUNS
- 439770017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-04
- Public Version
- 1
- Public Version Date
- 2022-02-14
- Public Version Status
- New
- Public Device Record Key
- 0fb49c55-6836-4b48-b9d2-8c2ac2987bbc
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058480754618 | GS1 |
Customer Contacts
- Phone
- +39 0558497943
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192210 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius