Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; 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 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; 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-6CC-AXDBA FDA UDI
- Primary DI / UDI-DI
- 00732094334944 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
FDA UDI
Over-the-Counter
No
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
Category: Electrocardiographic ambulatory recorder
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 2de37eda-f533-49cd-9921-ae0ae00a3a71 35 fields · synced May 30, 2026