An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency
| Company | Devices | Share |
|---|---|---|
| Boston Scientific Corporation | 46 | 55% |
| Medtronic, Inc. | 12 | 14% |
| Biotronik Se & Co. Kg | 10 | 12% |
| Microport Crm Srl | 10 | 12% |
| Cameron Health, Inc. | 2 | 2% |
| St. Jude Medical, Inc. | 1 | 1% |
| Ebr Systems, Inc. | 1 | 1% |
| Avanos Medical, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| OSR | Pacemaker/icd/crt non-implanted components | 74 |
| LWS | Implantable cardioverter defibrillator (non-CRT) | 31 |
| KRG | Programmer, pacemaker | 21 |
| NVZ | Pulse generator, permanent, implantable | 10 |
| LWP | Implantable pulse generator, pacemaker (non-CRT) | 3 |
| DXY | implantable pacemaker Pulse-generator | 2 |
Use these as the dimensions to specify in a tender line.
83 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac pulse generator programmer", from 8 companies. The largest labeler is Boston Scientific Corporation with 55% of records.
OSR (Pacemaker/icd/crt non-implanted components), LWS (Implantable cardioverter defibrillator (non-CRT)), KRG (Programmer, pacemaker), NVZ (Pulse generator, permanent, implantable)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.