Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; Australia power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface) FDA UDI
- Model / Reference
- 901144 FDA UDI
- Description
- XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; Australia power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface) FDA UDI
Identifiers
- Catalog Number
- XSCRIBE-6XC-BXAXA FDA UDI
- Primary DI / UDI-DI
- 00732094259063 FDA UDI
- 510(k) Number
- K152944 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable 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: Electrocardiographic lead set, reusable
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K152944 also covers:
- AM12Q — MORTARA INSTRUMENT, INC.
- Patient Cable Lead Set — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — MORTARA INSTRUMENT, INC.
- Q-Stress — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 9c34d9d7-f291-46c6-a695-99b7ac8933c7 36 fields · synced May 30, 2026