Identity
- Trade Name
- RScribe FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Electrocardiograph FDA UDI
- Model / Reference
- RSCRIBE-6GC-XXDAA FDA UDI
- Description
- Electrocardiograph FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817655022130 FDA UDI
- 510(k) Number
- K120865 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
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
No
FDA UDI
Category: Electrocardiograph, professional, multichannel
RScribe by Mortara Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiograph, professional, multichannel.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- ers2 1CH ECG Adapter US Set 5 pcs. — ergoline GmbH · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Premier Heart MCG Model VH12 — PREMIER HEART, LLC · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K120865 also covers:
- RScribe — MORTARA INSTRUMENT, INC.
- RScribe — MORTARA INSTRUMENT, INC.
- RScribe — MORTARA INSTRUMENT, INC.
- RScribe — MORTARA INSTRUMENT, INC.
- RScribe — MORTARA INSTRUMENT, INC.
- RScribe — MORTARA INSTRUMENT, INC.
- RScribe — MORTARA INSTRUMENT, INC.
- RScribe — MORTARA INSTRUMENT, INC.
- Welch Allyn, Inc. — Welch Allyn, Inc.
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
- Mortara Instrument, Inc.
Sources (1)
- FDA UDI 8ff40c0c-35c5-4aae-816a-c374686e09b7 36 fields · synced May 31, 2026