Vital Signs
300-Series ECG Leadwire, Individual Replacement, Green RL, Grabber, AHA, 150cm/60in
7manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Hebei (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 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Carefusion Finland 320 Oy |
|---|---|
| FDA product code | MLD |
| Device type | Monitor, St Segment With Alarm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Record published | 2016-09-14 |
| Record revised | 2024-06-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -22 to 140 °F |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8003276 | Withdrawn | |
| 8003275 | Withdrawn | |
| 545344 | Withdrawn | |
| 545354 | Withdrawn | |
| 8003274 | Withdrawn | |
| 545353 | Withdrawn | |
| 545346 | Withdrawn | |
| 545318 | Withdrawn | |
| 8001958 | Withdrawn | |
| 545317-HEL | Withdrawn | |
| 545328 | Withdrawn | |
| 545351 | Withdrawn | |
| 545358 | Withdrawn | |
| 545349 | Withdrawn | |
| 545345 | Withdrawn | |
| 8001959-HEL | Withdrawn | |
| 545327-HEL | Withdrawn | |
| 545359 | Withdrawn | |
| 545355 | Withdrawn | |
| 8003278 | Withdrawn | |
| 8003277 | Withdrawn | |
| 545352 | Withdrawn | |
| 545350 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 48 |
| Lifee | CAF Medical Solutions Inc | 7 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 7 |
| Athena GTX Device Management Suite (Adms) Software | Athena GTX | 2 |
| Monitor, St Segment With Alarm | GE Healthcare Finland OY | 2 |
| Xhibit Telemetry Receiver | Spacelabs Healthcare (Washington), Inc | 1 |
| Contec | Contec Medical Systems Co., Ltd. | 1 |
| Advanced Patient Monitor | Advanced Instrumentations, Inc. | 1 |
| Xhibit | Spacelabs Healthcare (Washington), Inc | 1 |
| Comen | Shenzhen Comen Medical Instruments Co., Ltd. | 1 |
| Patient Monitor | Edan Instruments, Inc. | 1 |
| XTR | Spacelabs Healthcare (Washington), Inc | 1 |
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.