Stand, Infusion
Bipolar Generator Cart
75manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FOX |
| Device type | Stand, Infusion |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6990 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-29 |
| Record revised | 2022-09-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 90 % RH; Handling environment temperature -20 to 50 °C; Storage environment temperature -20 to 50 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | In distribution | |
| 6700-313-700 | In distribution | |
| 1211-210-010 | In distribution | |
| 5027500200 | In distribution | |
| N/A | In distribution | |
| 1211-211-010 | 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
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 |
|---|---|---|---|---|---|
| 2015-10-13 | Class II | Process control | It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. | 19,876 | 2016-09-06 |
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.