Monitor, Breathing Frequency
Adult Divided Oral/Nasal Pressure Monitoring & Gas Sampling Cannula with modified nasal prongs Salter Eyes 7’ (2.1 m) tubes with male/female connector for gas sampling and male luer…
Adult Divided Oral/Nasal Pressure Monitoring & Gas Sampling Cannula with modified nasal prongs Salter Eyes 7’ (2.1 m) tubes with male/female connector for gas sampling and male luer connector for pressure monitoring.
8manufacturers in China registered for this device type
52catalogue numbers in this listing
1510(k) clearance
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 | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| 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, pack of 26, pack of 50, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5054-7-7 | Small Pediatric | In distribution |
| 5022-7 | Pediatric | In distribution |
| 5012-2 | Adult | In distribution |
| 5005-2 | Adult | In distribution |
| 5001-7 | Adult | In distribution |
| 5006-1 | Adult | In distribution |
| 5002-7 | Adult | In distribution |
| 5045-7-7 | Adult | In distribution |
| 5052-7-7 | Pediatric | In distribution |
| 5003-7 | Adult | In distribution |
| 5013-7 | Adult | In distribution |
| 5018-7-7-25 | Adult | In distribution |
| 5005-7 | Adult | In distribution |
| 5011-7 | Adult | In distribution |
| 5044-7-7 | Adult | In distribution |
| 5038-7 | Pediatric | In distribution |
| 5016-7 | Adult | In distribution |
| 5009-7-7 | Pediatric | In distribution |
| 5049-7-7 | Pediatric | In distribution |
| 5006-7 | Adult | In distribution |
| 5021-7 | Pediatric | In distribution |
| 5032-7-7 | Adult | In distribution |
| 5051-7-7 | Pediatric | In distribution |
| 5037-7 | Pediatric | In distribution |
| 5028-7-7 | Pediatric | In distribution |
| 5018-7-7 | Adult | In distribution |
| 5050-7-7 | Pediatric | In distribution |
| 5011-2 | Adult | In distribution |
| 5004-7 | Adult | In distribution |
| 5056-7-7 | Small Pediatric | In distribution |
| 5012-1 | Adult | In distribution |
| 5006-2 | Adult | In distribution |
| 5008-7-7 | Adult | In distribution |
| 5034-7 | Pediatric | In distribution |
| 5007-7-7 | Adult | In distribution |
| 5800-0 | Adult | In distribution |
| 5014-7 | Adult | In distribution |
| 5042-7-7 | Adult | In distribution |
| 5036-7 | Pediatric | In distribution |
| 5043-7-7 | Adult | In distribution |
| 5012-7 | Adult | In distribution |
| 5015-7 | Adult | In distribution |
| 5033-7 | Pediatric | In distribution |
| 5041-7-7 | Adult | In distribution |
| 5011-1 | Adult | In distribution |
| 5010-7-7 | Pediatric | In distribution |
| 5017-7-7 | Adult | In distribution |
| 5027-7-7 | Pediatric | In distribution |
| 5053-7-7 | Small Pediatric | In distribution |
| 5047-7-7 | Adult | In distribution |
| 5023-7 | Pediatric | In distribution |
| 5024-7 | Pediatric | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfect Fit | Dymedix Diagnostics Inc | 189 |
| Monitor, Breathing Frequency | ConMed Corporation | 106 |
| Conmed | ConMed Corporation | 46 |
| Cadwell | Cadwell Industries, Inc. | 44 |
| Sensor | Respironics Inc. | 42 |
| ThermiSense | Salter Labs | 33 |
| 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.