Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; No power cord; No printer; No accessories; AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing) FDA UDI
- Model / Reference
- 901127 FDA UDI
- Description
- RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; WAM Wireless Acquisition Module; Non-interpretive; Software kit; No power cord; No printer; No accessories; AHA 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing) FDA UDI
Identifiers
- Catalog Number
- RSCRIBE-6BC-XXDAA FDA UDI
- Primary DI / UDI-DI
- 00732094319026 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiograph, professional, multichannel
Welch Allyn, Inc. provides an RScribe 12-Lead Multi-Channel Electrocardiograph (ECG), a professional-grade device for assessing electrical cardiac physiology. This versatile instrument can be used in clinical settings to acquire and process heart activity, offering valuable insights into cardiovascular regulation.
Similar devices
Also classified as Electrocardiograph, professional, multichannel.
- ers2 1CH ECG Adapter US Set 5 pcs. — ergoline GmbH · Class II
- Premier Heart MCG Model VH12 — PREMIER HEART, LLC · Class II
- ELI 380 — MORTARA INSTRUMENT, INC. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- ELI 280 — MORTARA INSTRUMENT, INC. · Class II
- ELI 280 — MORTARA INSTRUMENT, INC. · Class II
- Venni / Biolight — VENNI INSTRUMENTS INC. · Class II
- ELI 150c — MORTARA INSTRUMENT, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI f1edc737-3ece-4668-af2d-c479b333d9ff 35 fields · synced Jul 15, 2026