Perfect Fit
Perfect Fit™ II R/S Pediatric Kit includes: 2- Perfect Fit™II R/S sensors, 2-15” Effort Belt Strap, 2-25” Effort Belt Strap, and 2-35” Effort Belt Strap and 2- R/S Interface Cable, Embla,…
Perfect Fit™ II R/S Pediatric Kit includes: 2- Perfect Fit™II R/S sensors, 2-15” Effort Belt Strap, 2-25” Effort Belt Strap, and 2-35” Effort Belt Strap and 2- R/S Interface Cable, Embla, 1.5 mm
8manufacturers in China registered for this device type
189catalogue numbers in this listing
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 | Dymedix Diagnostics Inc, United States |
|---|---|
| FDA product code | BZQ |
| Device type | Monitor, Breathing Frequency |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K040605 |
| Record published | 2018-10-05 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 20, pack of 10, pack of 50, pack of 40, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-01019-0601 | In distribution | |
| 11-23100-2502 | In distribution | |
| 11-45003-0002 | In distribution | |
| 11-45003-0001 | In distribution | |
| 11-42303-0601 | In distribution | |
| 11-30002-3002 | In distribution | |
| 18-01019-0301 | In distribution | |
| 12-42015-0001 | In distribution | |
| 11-45002-0002 | In distribution | |
| 12-42002-0001 | In distribution | |
| 11-42400-0601 | In distribution | |
| 18-01805-0001 | In distribution | |
| 18-01802-0001 | In distribution | |
| 11-23300-1502 | In distribution | |
| 11-43300-4502 | In distribution | |
| 11-43300-6002 | In distribution | |
| 11-43100-4501 | In distribution | |
| 11-45007-0001 | In distribution | |
| 18-12214-0302 | In distribution | |
| 18-14204-0602 | In distribution | |
| 11-45005-0001 | In distribution | |
| 18-14250-0601 | In distribution | |
| 11-42403-0601 | In distribution | |
| 11-94320-0601 | In distribution | |
| 18-13201-0001 | In distribution | |
| 11-22306-0301 | In distribution | |
| 11-43100-3002 | In distribution | |
| 11-42710-0601 | In distribution | |
| 11-42200-0601 | In distribution | |
| 11-22700-0301 | In distribution | |
| 11-22800-0301 | In distribution | |
| 11-94321-0601 | In distribution | |
| 18-01806-0001 | In distribution | |
| 11-44300-7502 | In distribution | |
| 12-42001-0001 | In distribution | |
| 12-41114-0001 | In distribution | |
| 11-42300-0601 | In distribution | |
| 18-01807-0001 | In distribution | |
| 18-14260-0601 | In distribution | |
| 18-12204-0302 | In distribution | |
| 11-23300-3502 | In distribution | |
| 12-41113-0301 | In distribution | |
| 11-42800-0601 | In distribution | |
| 12-42000-0001 | In distribution | |
| 18-01016-0301 | In distribution | |
| 11-94202-0601 | In distribution | |
| 11-45009-0001 | In distribution | |
| 11-44000-3002 | In distribution | |
| 11-22305-0301 | In distribution | |
| 11-43300-4501 | In distribution | |
| 11-42305-0601 | In distribution | |
| 12-42004-0001 | In distribution | |
| 18-13210-0001 | In distribution | |
| 12-42016-0001 | In distribution | |
| 18-01803-0001 | In distribution | |
| 11-23200-3502 | In distribution | |
| 18-14203-0602 | In distribution | |
| 18-14211-0602 | In distribution | |
| 11-42307-0601 | In distribution | |
| 11-30002-7502 | In distribution | |
| 11-44400-0001 | In distribution | |
| 11-94210-0602 | In distribution | |
| 11-30001-7502 | In distribution | |
| 11-43100-7502 | In distribution | |
| 18-01020-0301 | In distribution | |
| 18-01022-0601 | In distribution | |
| 18-12230-0302 | In distribution | |
| 18-13200-0001 | In distribution | |
| 11-22400-0301 | In distribution | |
| 12-42012-0001 | In distribution | |
| 12-42011-0001 | In distribution | |
| 18-01015-0301 | In distribution | |
| 18-01018-0301 | In distribution | |
| 11-14001-1001 | In distribution | |
| 18-01020-0601 | In distribution | |
| 18-14201-0602 | In distribution | |
| 18-01800-0001 | In distribution | |
| 11-45005-0002 | In distribution | |
| 11-22200-0301 | In distribution | |
| 18-12213-0302 | In distribution | |
| 12-41213-0001 | In distribution | |
| 18-14230-0602 | In distribution | |
| 18-12210-0302 | In distribution | |
| 12-42013-0001 | In distribution | |
| 18-14215-0602 | In distribution | |
| 12-41203-0001 | In distribution | |
| 12-41203-0301 | In distribution | |
| 11-45006-0001 | In distribution | |
| 18-01023-0301 | In distribution | |
| 11-43200-6002 | In distribution | |
| 11-23200-1502 | In distribution | |
| 12-42010-0001 | In distribution | |
| 18-14240-0602 | In distribution | |
| 11-45008-0001 | In distribution | |
| 11-43300-7502 | In distribution | |
| 18-01023-0601 | In distribution | |
| 11-22406-0301 | In distribution | |
| 18-13206-0001 | In distribution | |
| 11-45000-0002 | In distribution | |
| 18-13209-0001 | In distribution | |
| 11-42306-0601 | In distribution | |
| 12-41213-0301 | In distribution | |
| 11-30001-3002 | In distribution | |
| 18-01016-0601 | In distribution | |
| 11-45001-0002 | In distribution | |
| 11-94310-0602 | In distribution | |
| 11-42700-0601 | In distribution | |
| 11-43200-7502 | In distribution | |
| 11-45001-0001 | In distribution | |
| 18-12211-0302 | In distribution | |
| 11-42407-0601 | In distribution | |
| 11-94311-0602 | In distribution | |
| 18-13203-0001 | In distribution | |
| 18-01804-0001 | In distribution | |
| 11-94201-0601 | In distribution | |
| 11-45009-0002 | In distribution | |
| 11-22900-0302 | In distribution | |
| 12-42005-0001 | In distribution | |
| 18-01031-0001 | In distribution | |
| 18-01017-0301 | In distribution | |
| 18-13204-0001 | In distribution | |
| 11-45006-0002 | In distribution | |
| 11-22100-0301 | In distribution | |
| 11-43200-4501 | In distribution | |
| 11-14001-5001 | In distribution | |
| 11-44200-7501 | In distribution | |
| 12-41113-0001 | In distribution | |
| 18-13208-0001 | In distribution | |
| 11-22303-0301 | In distribution | |
| 11-45002-0001 | In distribution | |
| 18-14210-0602 | In distribution | |
| 12-10152-0001 | In distribution | |
| 18-14212-0602 | In distribution | |
| 11-23100-3502 | In distribution | |
| 12-42014-0001 | In distribution | |
| 18-12215-0302 | In distribution | |
| 18-14213-0602 | In distribution | |
| 18-01030-0001 | In distribution | |
| 11-42405-0601 | In distribution | |
| 11-43300-3002 | In distribution | |
| 11-23100-1502 | In distribution | |
| 18-01024-0301 | In distribution | |
| 12-42006-0001 | In distribution | |
| 11-42810-0601 | In distribution | |
| 11-43100-6002 | In distribution | |
| 18-12203-0302 | In distribution | |
| 11-42900-0602 | In distribution | |
| 18-12212-0302 | In distribution | |
| 11-44000-7502 | In distribution | |
| 11-44100-7501 | In distribution | |
| 11-43100-4502 | In distribution | |
| 12-10151-0001 | In distribution | |
| 18-12216-0302 | In distribution | |
| 12-42017-0001 | In distribution | |
| 18-13207-0001 | In distribution | |
| 18-01021-0601 | In distribution | |
| 18-01018-0601 | In distribution | |
| 11-23300-2502 | In distribution | |
| 18-01021-0301 | In distribution | |
| 18-01025-0601 | In distribution | |
| 18-14216-0602 | In distribution | |
| 18-01017-0601 | In distribution | |
| 18-01022-0301 | In distribution | |
| 18-01801-0001 | In distribution | |
| 18-14214-0602 | In distribution | |
| 11-45007-0002 | In distribution | |
| 11-22403-0301 | In distribution | |
| 11-22405-0301 | In distribution | |
| 11-45008-0002 | In distribution | |
| 11-23200-2502 | In distribution | |
| 18-12201-0302 | In distribution | |
| 11-45004-0001 | In distribution | |
| 11-43200-3002 | In distribution | |
| 18-01024-0601 | In distribution | |
| 11-94220-0602 | In distribution | |
| 11-42406-0601 | In distribution | |
| 11-45004-0002 | In distribution | |
| 12-42003-0001 | In distribution | |
| 18-13205-0001 | In distribution | |
| 11-22300-0301 | In distribution | |
| 12-42007-0001 | In distribution | |
| 11-94330-0602 | In distribution | |
| 18-12202-0302 | In distribution | |
| 18-14202-0602 | In distribution | |
| 11-43200-4502 | In distribution | |
| 11-42100-0601 | In distribution | |
| 18-01015-0601 | In distribution | |
| 11-45000-0001 | In distribution | |
| 18-13202-0001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
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.