Oxygen (O2) Tank Booster Accessory for Ivea
An accessory that attaches to IVEA to allow compatibility and placement of shorter (D size) oxygen tanks on the device
Who Else Makes It
Concentrated in Guangdong (33), Jiangsu (20), Zhejiang (6). 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 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| Foshan Huafukang Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| Jiangyin Newrise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 10 |
| Coriton Instrument Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Freudenberg Medical Plastic & Metal Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
Showing 12 of 75. All 75 manufacturers in China registered for Stand, Infusion
Record
| Listed by | Firefly Medical, Inc., United States |
|---|---|
| FDA product code | FOX |
| Device type | Stand, Infusion |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6990 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-07 |
| Record revised | 2024-12-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16289 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CIM med GmbH | CIM MED Gmbh | 614 |
| Pryor | Pryor Products | 225 |
| Patient Loading Utility System (Plus) | Lifeport, LLC. | 74 |
| ICU | Pryor Products | 66 |
| Stand, Infusion | MID Central Medical | 59 |
| BD | Pryor Products | 59 |
| Baxter | Pryor Products | 45 |
| Medi-VAC | Cardinal Health 200, LLC | 45 |
| Clinton Industries | Clinton Industries, Inc | 42 |
| Plus | Lifeport, LLC. | 40 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 39 |
| Smeed Technologies | Smeed Technologies LLC | 37 |
Showing 12 of 278. All products under Stand, Infusion
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2017-08-24 | Class II | Device Design | The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the | 570 units | 2019-11-01 |
| 2016-11-01 | Class II | Process control | The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble. | 239 | 2017-08-01 |
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.