Humidifier, Respiratory Gas, (Direct Patient Interface)
START-UP KIT THIS KIT CONTAINS: (2) - # 1606 Adult Nasal Cannula (1) - # 2025 Oxygen Tubing, 25’ (1) - # 7100 Bubble Humidifier, 3psi
12manufacturers in China registered for this device type
96catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Fujian (1). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Ninghai Guangjie Electronic Commerce Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 3 |
| Vincent Medical(Dongguan)Technology Company Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Salter Labs, United States |
|---|---|
| FDA product code | BTT |
| Device type | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K113542 |
| Record published | 2016-09-24 |
| Record revised | 2026-06-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -40 to 60 °C; Special storage condition: N/A; Handling environment temperature 5 to 40 °C |
| Packaging | Pack of 10, pack of 15, pack of 5, pack of 20, pack of 50, pack of 25 |
| Distribution end date | 2026-05-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SO-1676-0 | Adult | In distribution |
| SO-797-0 | Adult | In distribution |
| SO-1681-0 | Adult | In distribution |
| SO-1858-0 | Adult | In distribution |
| 7125-25 | Adult | In distribution |
| SO-1613-0 | In distribution | |
| SO-1928-0 | Adult | In distribution |
| SO-1352 | Adult | In distribution |
| SO-1320 | Adult | In distribution |
| SO-1142 | Adult | In distribution |
| SO-1499-0 | Adult | In distribution |
| SO-1896-0 | Adult | In distribution |
| SO-1393 | Adult | In distribution |
| SO-531-0 | Adult | In distribution |
| SO-1394 | Adult | In distribution |
| SO-1635-0 | In distribution | |
| SO-1507-0 | Adult | In distribution |
| SO-1958-0 | Adult | In distribution |
| SO-1801-0 | Adult | In distribution |
| SO-1370 | Adult | In distribution |
| SO-1683-0 | Adult | In distribution |
| SO-1840-0 | Adult | In distribution |
| SO-663-0 | Adult | In distribution |
| SO-610-0 | Adult | In distribution |
| SO-1738-0 | Adult | In distribution |
| SO-1341 | Adult | In distribution |
| 7100-0 | In distribution | |
| 7150-50 | Adult | In distribution |
| 79SOFT-14 | Adult | In distribution |
| E7100-0 | In distribution | |
| 7925-25 | Adult | In distribution |
| SO-1980-0 | Adult | In distribution |
| SO-1767-0 | Adult | In distribution |
| SO-1999 | In distribution | |
| 7600-0 | In distribution | |
| SO-1950-0 | Adult | In distribution |
| SO-1870-0 | Adult | In distribution |
| SO-1321-0 | Adult | In distribution |
| SO-1385-0 | Adult | In distribution |
| SO-564-0 | Adult | In distribution |
| SO-2052 | Adult | In distribution |
| SO-1959-0 | Adult | In distribution |
| SO-1308-0 | Adult | In distribution |
| SO-1380 | Adult | In distribution |
| SO-1956-0 | Adult | In distribution |
| SO-1475 | Adult | In distribution |
| SO-1481-0 | Adult | In distribution |
| SO-1979-0 | Adult | In distribution |
| 7907TLC-7 | In distribution | |
| SO-1881-0 | In distribution | |
| SO-500-0 | Adult | In distribution |
| SO-708-0 | Adult | In distribution |
| SO-1343 | Adult | In distribution |
| NP7600-0 | In distribution | |
| SO-1768-0 | Adult | In distribution |
| SO-1325 | Adult | In distribution |
| SO-1682-0 | Adult | In distribution |
| SO-1871-0 | Adult | In distribution |
| 79SOFT-25 | Adult | In distribution |
| 79SOFT-7 | Adult | In distribution |
| SO-1666-0 | Adult | In distribution |
| SO-1315 | Adult | In distribution |
| SO-1658-0 | Adult | In distribution |
| SO-1756-0 | Adult | In distribution |
| M833576-0 | In distribution | |
| M010854 | In distribution | |
| SO-522-0 | Adult | In distribution |
| SO-1905-0 | Adult | In distribution |
| E7600-0 | In distribution | |
| AR-7600 | In distribution | |
| M7600-0 | In distribution | |
| SO-1319 | Adult | In distribution |
| NP7100-0 | Small Pediatric | In distribution |
| E7900-0 | Adult | In distribution |
| SO-1456 | Adult | In distribution |
| SO-1477-0 | Adult | In distribution |
| SO-648-0 | Adult | In distribution |
| SO-1680-0 | In distribution | |
| 7914TLC-14 | Adult | In distribution |
| SO-1818-0 | In distribution | |
| SO-1855-0 | Adult | In distribution |
| 7914-14 | Adult | In distribution |
| SO-1927 | Adult | In distribution |
| SO-1852-0 | Adult | In distribution |
| 7907-7 | Adult | In distribution |
| 7900-0 | Adult | In distribution |
| SO-1949-0 | Adult | In distribution |
| SO-1667-0 | Adult | In distribution |
| M5120-0 | In distribution | |
| SO-1662-0 | Adult | In distribution |
| SO-1392-0 | Adult | In distribution |
| SO-1608-0 | Adult | In distribution |
| M123138-0 | In distribution | |
| SO-1690-0 | In distribution | |
| L7600-0 | Withdrawn | |
| SO-562-0 | Adult | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 160 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 151 |
| Vapotherm | Vapotherm Inc. | 134 |
| Hudson RCI | Medline Industries, Inc. | 41 |
| AirLife™ | Airlife, Inc. | 27 |
| Fisher and Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 20 |
| F&P Optiflow Junior 2 | Fisher & Paykel Healthcare, Ltd. | 17 |
| MR850 | Fisher & Paykel Healthcare, Ltd. | 13 |
| AirLife | Carefusion | 13 |
| softFlow | TNI Medical AG | 11 |
| F&P Optiflow+ | Fisher & Paykel Healthcare, Ltd. | 7 |
| AnaPod | Westmed, Inc. | 7 |
Showing 12 of 138. All products under Humidifier, Respiratory Gas, (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161719 | 2017-09-21 |
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.