LiDCO
LiDCO Module, L, 1/Box
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Masimo Corporation, United States |
|---|---|
| FDA product code | DXG |
| Device type | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1435 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K163334 |
| Record published | 2024-07-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 95 % RH; Handling environment humidity 10 to 95 % RH; Handling environment temperature 0 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95060 | In distribution | |
| 95099 | In distribution | |
| 95059 | In distribution | |
| 95098 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LiDCO Ltd | Lidco Ltd. | 133 |
| LiDCO | Lidco Ltd. | 32 |
| Transonic | Transonic Systems, Inc. | 31 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Edwards Lifesciences Technology Sarl | 23 |
| Retia Medical | Retia Medical, LLC | 17 |
| EV1000 | Edwards Lifesciences Technology Sarl | 11 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | GE Healthcare Finland OY | 5 |
| Pediasat | Edwards Lifesciences Technology Sarl | 4 |
| ICU Medical | ICU Medical, Inc | 4 |
| Cnap® Monitor 500 HD | Cnsystems Medizintechnik GmbH | 4 |
| Vigileo | Edwards Lifesciences Technology Sarl | 3 |
| Starling | Cheetah Medical (Israel) Ltd | 3 |
Showing 12 of 39. All products under Computer, Diagnostic, Pre-Programmed, Single-Function
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Lidco Ltd. | 510(k) number | 2020-11-19 | Class II | Labeling mix-ups | The expiration date on labeling is incorrect. | 40 packs (5 each per pack) | 2022-09-26 |
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.