M Series Biphasic
Defibrillator ,MAIN, EMTD-1, 12 LEAD, BLUETOOTH,MUSE, SPO2, BIPHASIC, AC, PACE, RCD, SMR, CDMK, DMST
2manufacturers in China registered for this device type
97catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | DRO |
| Device type | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5550 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2014-09-19 |
| Record revised | 2026-02-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure from 0 KiloPascal; Storage environment temperature -20 to 60 °C; Handling environment temperature 0 to 55 °C |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40021221100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010521100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100013011 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021511100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021711100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010711101124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100103011 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021711100063010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021711100173010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010511100023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021221100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021221100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010211110063010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010711100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021311100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011110123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010211100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010211100173010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010711100003010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010211100063010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021721100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010311100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010511100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010311100024010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021211100023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022311100023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60022311100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010511100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021211100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010011100103011 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021311100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021321100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021011100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010311100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010311100173010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010311100173010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010511100024010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021311100003010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60022311100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010011110123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022211110103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022711110163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021011100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021021100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021311100024010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022211100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010221100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010511100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021731100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021511100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100010011 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010011100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010711100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010531100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021711100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010311110163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021311100003010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010211101023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010511110123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022211110163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021511100003010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021761100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100003011 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010521100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021511110103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022511100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021211100124010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011110163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010311101103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022011100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100073011 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010211110103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010211110023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021211110123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021111100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022511100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010311100003010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021731100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021221100024010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022311100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021221100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010010100013013 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021511100023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010711100023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40022711100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010761100173010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010321100024010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010021100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021511100103010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60021311100173010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010011100163010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40010511100123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021011100023010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 40021521110123010 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
| 60010211100163011 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Defibrillation Electrodes | TZ Medical, Inc. | 31 |
| Medi-Trace Cadence | Cardinal Health | 17 |
| Kendall | Cardinal Health | 5 |
| R Series | Zoll Medical Corporation | 5 |
| HeartStart | Philips Medical Systems Hsg | 2 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Philips Medical Systems Hsg | 2 |
| PAD 3020-XLT | TZ Medical, Inc. | 1 |
| Pedi-Padz | Zoll Medical Corporation | 1 |
| PAD 1115Z | TZ Medical, Inc. | 1 |
| Pad 101NHK | TZ Medical, Inc. | 1 |
| PAD 1114 | TZ Medical, Inc. | 1 |
| PAD 3020-HP | TZ Medical, Inc. | 1 |
Showing 12 of 36. All products under Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950856 | 1995-12-29 |
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.