Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG, 5-Lead Wire Set, safety DIN .060, snap for use with 008-0314-01 (IEC) FDA UDI
- Model / Reference
- 901006 FDA UDI
- Description
- ECG, 5-Lead Wire Set, safety DIN .060, snap for use with 008-0314-01 (IEC) FDA UDI
Identifiers
- Catalog Number
- 008-0322-01 FDA UDI
- Primary DI / UDI-DI
- 00732094035261 FDA UDI
- 510(k) Number
- K972121 FDA UDI
- FDA Product Code
- MLD FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
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
K972121 also covers:
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, Inc.
- Welch Allyn, Inc. — Welch Allyn, 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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI a93d2e9d-5bd7-4b97-bc75-a2b1ec1c78b3 36 fields · synced Jun 1, 2026