A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), d
| Company | Devices | Share |
|---|---|---|
| Danlee Medical Products, Inc | 375 | 84% |
| Graphic Controls Acquisition Corp | 28 | 6% |
| Lynn Medical Instrument Co. | 21 | 5% |
| Florida Medical Sales Inc | 8 | 2% |
| Spacelabs Healthcare (Washington), Inc | 5 | 1% |
| Midmark Corporation | 3 | 1% |
| Henry Schein, Inc. | 3 | 1% |
| Vectracor Inc | 1 | 0% |
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 |
|---|---|---|
| DRX | Electrode, Electrocardiograph | 8 |
| MWJ | Electrocardiograph, ambulatory (without analysis) | 4 |
| DRX | Electrode, electrocardiograph | 3 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 |
| OJW | Shave Prep Kit | 1 |
| DSH | RECORDER, MAGNETIC TAPE, MEDICAL | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
444 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic long-term ambulatory recording support kit", from 8 companies. The largest labeler is Danlee Medical Products, Inc with 84% of records.
DRX (Electrode, Electrocardiograph), MWJ (Electrocardiograph, ambulatory (without analysis)), DRX (Electrode, electrocardiograph), MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
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.