Trulink
Sample Line,agent,w/Sampling TEE,10',50/BX
6manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), 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 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | CBR |
| Device type | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1700 |
| 510(k) | K112173 |
| Record published | 2024-04-22 |
| Record revised | 2024-06-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NIBP Hoses and adapters | 1.19mm/0.047in ID, 305 cm/10 ft length | 50 | In distribution |
| NIBP Hoses and adapters | 1.19mm/0.047in ID, 305 cm/10 ft length | 50 | In distribution |
| NIBP Hoses and adapters | 1.19mm ID, 213 cm length | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 4 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| 19″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 22″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| UltraviewSL | Spacelabs Healthcare (Washington), Inc | 1 |
| AG Module(O2/package/accessory) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 19″display(adapter/10M/VP1) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Spacelabs | Spacelabs Healthcare (Washington), Inc | 1 |
| Carescape B850 | GE Healthcare Finland OY | 1 |
| SMR integrated mount accessory Kit | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
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 |
|---|---|---|---|---|---|---|---|
| Spacelabs Healthcare Ltd. | 510(k) number | 2014-06-18 | Class II | Process control | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. | 8 units total (3 units in US) | 2014-12-08 |
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.