Iradimed
Cuff, NIBP, Small Adult Reusable (20.5-28.5 cm)
17manufacturers in China registered for this device type
59catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (10), Beijing (2), Jiangsu (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Armorlink SH Corp | Shanghai | Shanghai | Contract manufacturer | 2 |
| Tontec Precision Plastics Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
Showing 12 of 17. All 17 manufacturers in China registered for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Record
| Listed by | Iradimed Corporation, United States |
|---|---|
| FDA product code | MWI |
| Device type | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K172200 |
| Record published | 2022-06-09 |
| Record revised | 2022-11-28 (version 7) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3880-1 | In distribution | |
| 1822A-25 | In distribution | |
| 3882 | In distribution | |
| 1884 | In distribution | |
| 1841-25 | In distribution | |
| 1834AL-10 | In distribution | |
| 1842A-25 | In distribution | |
| 1188 | In distribution | |
| 1844P-25 | In distribution | |
| 1843A-25 | In distribution | |
| 1822N-25 | In distribution | |
| 1842P-25 | In distribution | |
| 1844A-25 | In distribution | |
| 3883-1 | In distribution | |
| 1834I-10 | In distribution | |
| 1834C-10 | In distribution | |
| 1846-25 | In distribution | |
| 1832SA | In distribution | |
| 1832A-LONG | In distribution | |
| 1832LA | In distribution | |
| 1831 | In distribution | |
| 1822I-25 | In distribution | |
| 1822P-25 | In distribution | |
| 1862 | In distribution | |
| 1833N3-10 | In distribution | |
| 1888 | In distribution | |
| 1882-3 | In distribution | |
| 1887 | In distribution | |
| 1842I-25 | In distribution | |
| 3883-2 | In distribution | |
| 1832I | In distribution | |
| 3880-3 | In distribution | |
| 3883 | In distribution | |
| 3881 | In distribution | |
| 1195 | In distribution | |
| 3885T | In distribution | |
| 3880-2 | In distribution | |
| 3885B | In distribution | |
| 1833N4-10 | In distribution | |
| 3886 | In distribution | |
| 1811 | In distribution | |
| 1832A | In distribution | |
| 1861 | In distribution | |
| 1845-25 | In distribution | |
| 1863 | In distribution | |
| 1833N1-10 | In distribution | |
| 3883-3 | In distribution | |
| 1851 | In distribution | |
| 1891 | In distribution | |
| 1834SA-10 | In distribution | |
| 1832P | In distribution | |
| 3880 | In distribution | |
| 1833N2-10 | In distribution | |
| 1883 | In distribution | |
| 1881 | In distribution | |
| 1843P-25 | In distribution | |
| 1190-12 | In distribution | |
| 3880-4 | In distribution | |
| 1171 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 501 |
| SmartLinx Vitals Plus | Philips North America LLC | 174 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 154 |
| Capsule Vitals Plus | Philips North America LLC | 64 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies, Inc. | 44 |
| Medrad® Veris™ 8600 Vital Signs Monitor | Bayer Medical Care Inc. | 26 |
| Xper Flex Cardio Physiomonitoring System | Philips DS North America LLC | 24 |
| Wvsm Wireless Vital Signs Monitor | Athena GTX | 23 |
| 740 Select | ZOE Medical, Inc. | 20 |
| Wvsm Pro, Wireless Vital Signs Monitor Professional | Athena GTX | 20 |
| BioStamp nPoint™ | Medidata Solutions, Inc. | 19 |
| BioStamp nPoint™ | Mc10, Inc. | 18 |
Showing 12 of 314. All products under Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180903 | 2019-03-29 |
| K182900 | 2018-12-14 |
| K172200 | 2017-10-25 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Iradimed Corporation | 510(k) number | 2023-02-24 | Class II | Process control | Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occ | 3285 boxes of 50 devices | |
| Iradimed Corporation | 510(k) number | 2013-07-01 | Class I | Software Manufacturing/Software Deployment | The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is | 176 individuals kits | 2015-07-13 |
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.