FDA UDI
In Commercial Distribution
🇺🇸 United States
SENSIMED Triggerfish® Data Cable
DI: 07640153470140
·
Model: DC.V.5.1
·
Sensimed SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SENSIMED Triggerfish® Data Cable
- Primary DI
- 07640153470140
- Version / Model
- DC.V.5.1
- Catalog Number
- ST5010
- Company Name
- Sensimed SA
- Labeler DUNS
- 482491177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 66a13886-68c2-4236-a09a-87c946884ad1
Device Description
An electrical cable with connector that connects the SENSIMED Triggerfish® Recorder device with SENSIMED Triggerfish® eye patch antenna, used to transmit electrical power and data in between
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| PLZ | Ocular Pattern Recorder | Ophthalmic | 886.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62115 | Ambulatory monitoring/recording system transceiver/cable | An electronic component of an ambulatory patient monitoring/recording system (e.g., ocular volume ambulatory recording system) designed to connect a patient-worn antenna to an ambulatory monitor/recorder for receiving and transmitting data between an implantable or nonimplantable sensor (used in close proximity to the antenna) and the monitor/recorder; it may also be intended to allow wireless power transfer from the parent device to the sensor via the antenna. It is in the form of an electronic circuitry housing with a cable and is powered by the monitor/recorder (battery-powered). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640153470140 | GS1 |
Customer Contacts
- Phone
- +41216219191
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN140017 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 20.67 – 31.3 Inches of Mercury
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 23.62 – 31.3 Inches of Mercury