Identity
- Trade Name
- Unimed FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- One piece EKG Diagnosis Cable/Kenz/10-lead/4mm banana plug/AHA/2.2M+1.2M*4+0.8M*6/356 FDA UDI
- Model / Reference
- E10R-KZ2-B FDA UDI
- Description
- One piece EKG Diagnosis Cable/Kenz/10-lead/4mm banana plug/AHA/2.2M+1.2M*4+0.8M*6/356 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945664837637 FDA UDI
- FDA Product Code
- DSA FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2900 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
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
Unimed by Unimed Medical Supplies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- AMC — Advantage Medical Electronics, LLC · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
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- APK — Apk Technology · Class II
- AMC — Advantage Medical Electronics, LLC · Class II
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
- Unimed Medical Supplies, Inc.
Sources (1)
- FDA UDI 8753e2bf-b322-4abd-ada3-b06295bb1222 33 fields · synced Jun 6, 2026