SG 218 Aerosol Tee Adapter
The SG 218 Aerosol Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Dimensions: 22mm O.D. x 18mm I.D./22mm O.D. x 18mm I.D./22mm O.D Reusable.
Who Else Makes It
Concentrated in Zhejiang (18), Guangdong (18), Jiangsu (5). 18 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 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | 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 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
Showing 12 of 55. All 55 manufacturers in China registered for Circuit, Breathing (W Connector, Adaptor, Y Piece)
Record
| Listed by | Instrumentation Industries, Incorporated, United States |
|---|---|
| FDA product code | CAI |
| Device type | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-30 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide, High-level Disinfectant |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Ziplock bag of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SG 218 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 3,457 |
| Vital Signs™ | Airlife, Inc. | 1,018 |
| Hudson RCI | Teleflex Medical LLC | 176 |
| Vital Signs™ | AirLife Finland Oy | 143 |
| Universal F2®ANESTHESIA Breathing Circuit | King Systems Corporation. | 133 |
| Universal FLEX2®BREATHING Circuit | King Systems Corporation. | 123 |
| Adult Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 111 |
| Portex | ICU Medical, Inc | 95 |
| AincA® | Anesthesia Associates, Inc. | 76 |
| Medline/MMS Sales | Medline Industries, Inc. | 73 |
| Pediatric Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 71 |
| Vital Signs™ | Vyaire Medical, Inc. | 70 |
Showing 12 of 522. All products under Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K830475 | 1983-06-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-11-13 | Class II | Labeling Change Control | Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. | 220 | 2014-07-09 |
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.