Identity
- Trade Name
- HScribe FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- Holter Analysis System FDA UDI
- Model / Reference
- HSCRIBEWS-6AC-YXXXX FDA UDI
- Description
- Holter Analysis System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812345029826 FDA UDI
- 510(k) Number
- K004017 FDA UDI
- FDA Product Code
- MLO FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software 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
No
FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyser application software
HScribe by Mortara Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic long-term ambulatory recording analyser application software.
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Vasomedical-Biox™ ARCS ABP Analysis & Reporting Software & Dongle — VASOMEDICAL, INC. · Class II
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Cleared under the same submission
K004017 also covers:
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, INC.
- HScribe — MORTARA INSTRUMENT, 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 59358f14-238a-4460-ba58-9e2936ccad4a 36 fields · synced Jun 1, 2026