MyCareLink Smart™
MON 25000 Mycarelink Smart US
79manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (29), Zhejiang (24), Guangdong (8). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Shanghai Huayue Packaging Products Co., Ltd. | Fengxian District | Shanghai | Contract manufacturer | 18 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 79. All 79 manufacturers in China registered for Container, Specimen, Sterile
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | FMH |
| Device type | Container, Specimen, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | P890003 |
| Record published | 2020-06-26 |
| Record revised | 2019-02-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature 59 to 86 °F; Storage environment humidity 5 to 95 % RH; Handling environment temperature -40 to 158 °F |
| Distribution end date | 2022-03-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25000 | Withdrawn | |
| 25000 | Withdrawn | |
| 25000 | Withdrawn | |
| 25000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 103 |
| Corning® | Corning Incorporated | 49 |
| Cardinal Health | Cardinal Health 200, LLC | 42 |
| Medline | Medline Industries, Inc. | 41 |
| Bioseal Inc. | Bioseal | 37 |
| Centurion | Centurion Medical Products Corporation | 29 |
| Globe Scientific | Globe Scientific, LLC | 29 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 27 |
| Sterile Specimen Container | Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V. | 20 |
| Vacuette | Greiner BIO-ONE Gmbh | 19 |
| Precision | Cardinal Health | 15 |
| Dover | Cardinal Health | 14 |
Showing 12 of 182. All products under Container, Specimen, Sterile
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic, Inc. | UDI-DI | 2017-07-14 | Class II | Error in labeling | Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient’s heart devices. Potential impacts could lead to missed Care | 1,519,984 enrollments total | 2024-06-28 |
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.