NEO-fit
NEO-fit Neonatal Endotracheal Tube grip
14manufacturers in China registered for this device type
1catalogue number
1recall
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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | JAY |
| Device type | Support, Breathing Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5280 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-30 |
| Record revised | 2024-02-28 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 20, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42-2540 | 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
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 |
|---|---|---|---|---|
| 2022-10-20 | Class II | Under Investigation by firm | Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient’s mouth. In one case, the patient s | 220,500 devices |
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.