ThermiSense
ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' long Malleable plastic coated "T" shaped with 2 nasal and 1 oral elements for thermal airflow. Two…
ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6′ long Malleable plastic coated “T” shaped with 2 nasal and 1 oral elements for thermal airflow. Two female touch proof 1.5 mm Din Connectors for connection to the Alice® 5 PSG System.
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Hebei (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Dongguan Smart Manufacturing Partner Electronic Company Limited | Dongguan | Guangdong | Contract manufacturer | 1 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Salter Labs, United States |
|---|---|
| FDA product code | BZQ |
| Device type | Monitor, Breathing Frequency |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151874 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature -40 to 60 °C |
| Packaging | Pack of 25, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5700A3-0-1 | Adult | In distribution |
| 5761-7 | Adult | In distribution |
| 5700T-0-1 | Adult | In distribution |
| 5742-7-7 | Adult | In distribution |
| 5700PE-0-1 | Pediatric | In distribution |
| 5700PT-0 | Pediatric | In distribution |
| 5700-0 | Adult | In distribution |
| 5700A4-0-1 | Adult | In distribution |
| 5751-2 | Adult | In distribution |
| 5700PCK-2-0-1 | Pediatric | In distribution |
| 5700E-0 | Adult | In distribution |
| 5700B-0 | Adult | In distribution |
| 5700S20-0 | Adult | In distribution |
| 5700EK-2-0 | Adult | In distribution |
| 5754-2-2 | Adult | In distribution |
| 5700EK-0 | Adult | In distribution |
| 5700PA3-0-1 | Pediatric | In distribution |
| 5700CK-2-0 | Adult | In distribution |
| 5700PS20-0 | Pediatric | In distribution |
| 5755-7-7 | Adult | In distribution |
| 5744-7-7 | Adult | In distribution |
| 5700PA5-0 | Pediatric | In distribution |
| 5750-7 | Adult | In distribution |
| 5760-7 | Adult | In distribution |
| 5700A5-0 | Adult | In distribution |
| 5751-7 | Adult | In distribution |
| 5730P-0 | Pediatric | In distribution |
| 5700PEK-2-0 | Adult | In distribution |
| 5700P-0 | Pediatric | In distribution |
| 5700PE-0 | Pediatric | In distribution |
| 5700PEK-0 | Adult | In distribution |
| 5761-2 | Adult | In distribution |
| 5754-7-7 | Adult | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfect Fit | Dymedix Diagnostics Inc | 189 |
| Monitor, Breathing Frequency | ConMed Corporation | 106 |
| Monitor, Breathing Frequency | Salter Labs | 52 |
| Conmed | ConMed Corporation | 46 |
| Cadwell | Cadwell Industries, Inc. | 44 |
| Sensor | Respironics Inc. | 42 |
| SnuggleFit | Dymedix Diagnostics Inc | 23 |
| Braebon Cable for Disposable RIP | Braebon Medical Corp. | 5 |
| PneumoTherm | Salter Labs | 4 |
| BiNAPS | Salter Labs | 4 |
| SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice | Ambu A/S | 4 |
| Braebon PT2 Dual Differntial Airflow Pressure Kit | Braebon Medical Corp. | 3 |
Showing 12 of 248. All products under Monitor, Breathing Frequency
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092685 | 2009-11-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.