Cannula
Salter Style® Nasal Cannula (INFANT), 7' (2.1 m) Supply tube
97manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (33), Guangdong (23), Jiangsu (17). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 97. All 97 manufacturers in China registered for Cannula, Nasal, Oxygen
Record
| Listed by | Salter Labs, United States |
|---|---|
| FDA product code | CAT |
| Device type | Cannula, Nasal, Oxygen |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5340 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-30 |
| Record revised | 2022-03-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16SOFTTG-INF-7 | Infant | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cannula, Nasal, Oxygen | Salter Labs | 394 |
| Hudson RCI | Teleflex Medical LLC | 92 |
| AirLife™ | Vyaire Medical, Inc. | 61 |
| Medline | Medline Industries, Inc. | 53 |
| AirLife™ | Airlife, Inc. | 51 |
| Hudson RCI | Medline Industries, Inc. | 44 |
| Vapotherm | Vapotherm Inc. | 41 |
| Curaplex | Bound Tree Medical, LLC | 39 |
| McKesson | Mckesson Medical-Surgical Inc. | 38 |
| Curaplex | TRI-Anim Health Services, Inc. | 35 |
| Create Biotech | Create Biotech Co., Ltd. | 34 |
| ProCure | Twin Med, LLC | 32 |
Showing 12 of 402. All products under Cannula, Nasal, Oxygen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K911740 | 1991-07-24 |
| K863431 | 1986-09-18 |
| K863432 | 1986-09-18 |
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.