Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- RScribe 12-Lead Multi-Channel Electrocardiograph - version 7, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); IEC 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 7, current software CD; WAM Wireless Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); IEC 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-7AC-XXABA FDA UDI
- Primary DI / UDI-DI
- 00732094262964 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
- Not 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
Yes
FDA UDI
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 1ef8dae9-a5d1-46f2-b1b4-6a1e71ab3982 36 fields · synced Jun 7, 2026