Welch Allyn, Inc.
Blue Max Supatab resting tab electrodes, wet gel, 33mm (1.30 in.). 100 electrodes/pack. Price per pack. Must order in increments of 24.
7manufacturers in China registered for this device type
48catalogue 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 | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | MLD |
| Device type | Monitor, St Segment With Alarm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K972121 |
| Record published | 2016-09-17 |
| Record revised | 2024-06-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 50, pack of 10 |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 901062 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901011 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901011 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | 100 | In distribution | |
| 901011 | In distribution | ||
| 901011 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901011 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901011 | In distribution | ||
| 901006 | In distribution | ||
| 901011 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901011 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901006 | In distribution | ||
| 901011 | In distribution | ||
| 901011 | In distribution | ||
| 901052 | Withdrawn | ||
| 901006 | Withdrawn | ||
| 901052 | Withdrawn | ||
| 901006 | Withdrawn | ||
| 901006 | Withdrawn | ||
| 901052 | Withdrawn | ||
| 901006 | Withdrawn | ||
| 901052 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vital Signs | Carefusion Finland 320 Oy | 23 |
| 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.