SunMed
Tube Tree Clear NON-Metallic Universal
14manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 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 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Jan Mao Industries Co., Ltd. | Baise | Guangxi | Manufacturer | 29 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Ningbo Huakun Medical Equipment Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 19 |
| Shaoxing Haitech Medical Products Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 13 |
Showing 12 of 14. All 14 manufacturers in China registered for Support, Breathing Tube
Record
| Listed by | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | JAY |
| Device type | Support, Breathing Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5280 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8-0038-04 | In distribution | |
| 8-0038-01 | In distribution | |
| 8-0038-03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeoHug® | Neotech Products, LLC | 20 |
| NeoGrip® | Neotech Products, LLC | 11 |
| Support, Breathing Tube | Hans Rudolph, Inc. | 8 |
| Capette™ | SunMed Group Holdings, LLC | 6 |
| Capette | Westmed, Inc. | 6 |
| AincA® | Anesthesia Associates, Inc. | 4 |
| Strapette™ | SunMed Group Holdings, LLC | 4 |
| Septal-H™ | SunMed Group Holdings, LLC | 4 |
| Strapette | Westmed, Inc. | 4 |
| ICU Medical, Inc. | ICU Medical, Inc | 4 |
| CS-ARM | W.T. Farley, Inc. | 4 |
| Support, Breathing Tube | VBM Medizintechnik Gmbh | 4 |
Showing 12 of 63. All products under Support, Breathing Tube
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.