ThermiSense 5754-7-7
GUDID 20607411000175
ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor Holder with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring.
SALTER LABS
Respiratory apnoea monitoring system| Primary Device ID | 20607411000175 |
| NIH Device Record Key | 31ef4b42-112e-445c-828b-537ca890f4ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThermiSense |
| Version Model Number | 5754-7-7 |
| Catalog Number | 5754-7-7 |
| Company DUNS | 022721133 |
| Company Name | SALTER LABS |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607411000171 [Primary] |
| GS1 | 10607411000178 [Package] Contains: 00607411000171 Package: [10 Units] In Commercial Distribution |
| GS1 | 20607411000175 [Package] Contains: 10607411000178 Package: [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151874
FDA Product Code
| BZQ | Monitor, breathing frequency |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [ThermiSense]
| 00607411893476 | ThermiSense® (Pediatric) Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusabl |
| 00607411891847 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/ |
| 00607411401237 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable. |
| 10607411301596 | ThermiSense® Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder 2' (0.6 m) tube wit |
| 00607411301506 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' long Malleabl |
| 00607411301490 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor Alice®4 with Airflow Pressure Cannulas, Nasal |
| 00607411301483 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor Alice®3 with Airflow Pressure Cannulas, Nasal |
| 00607411301339 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/ |
| 20607411301241 | ThermiSense® Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder 7' (2.1 m) tube wit |
| 20607411301234 | ThermiSense® Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder 7' (2.1 m) tube wit |
| 00607411301001 | ThermiSense® Interface Box For Use with ThermiSense® Oral/Nasal Thermal Air Flow Sensor No. 57 |
| 00607411300998 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor without Interface Box (5700B). |
| 20607411300985 | ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 7' (2.1 m) tu |
| 10607411300971 | ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 7' (2.1 m) tu |
| 20607411201121 | ThermiSense® Oral/Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor |
| 00607411099540 | ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' lon |
| 00607411005725 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with the Sandman® SD20 PSG System. Reu |
| 10607411005593 | ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with Thermistor Holder wi |
| 00607411000492 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor (Pediatric) for use with a PSG System. Reusable |
| 00607411000485 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor (Pediatric) for use with a PSG System. Reusable |
| 10607411000451 | ThermiSense® Oral/Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with Thermistor Hold |
| 10607411000437 | ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 2' (0.61 m) t |
| 00607411000416 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable. |
| 00607411000300 | ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable. |
| 00607411000256 | ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' lon |
| 00607411000249 | ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor without Interface Box (5700B). Reusab |
| 00607411000232 | ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' lon |
| 00607411000201 | ThermiSense® (Pediatric) Oral/Nasal Thermal Air Flow Sensor Alice®3 with Airflow Pressure Cann |
| 00607411000195 | ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal |
| 10607411000185 | ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor Holde |
| 20607411000175 | ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor Holde |
| 00607411000164 | ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable. |
Trademark Results [ThermiSense]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMISENSE 77485252 3604151 Live/Registered |
Salter Labs 2008-05-28 |
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