External Water Supply Module
Catalogue number 115-005403-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | JGS |
| Device type | Electrode, Ion Specific, Sodium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1665 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K160370 |
| Record published | 2016-09-23 |
| Record revised | 2022-12-08 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-005403-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 13 |
| i-STAT | Abbott Point OF Care Inc. | 9 |
| AU | Beckman Coulter, Inc. | 8 |
| GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 | Instrumentation Laboratory SPA | 8 |
| Nova | Nova Biomedical Corporation | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 5 |
| Sodium Electrode | Roche Diagnostics Gmbh | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Sodium Electrode | Diamond Diagnostics Inc. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 2 |
Showing 12 of 88. All products under Electrode, Ion Specific, Sodium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160370 | 2016-06-09 |
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 |
|---|---|---|---|---|---|---|---|
| Mindray DS USA, Inc. | 510(k) number | 2019-12-09 | Class II | Nonconforming Material/Component | The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers. | 7 | 2020-09-17 |
| Mindray DS USA, Inc. | 510(k) number | 2019-12-09 | Class II | Nonconforming Material/Component | The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers. | 6 | 2020-09-17 |
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.