Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed 14/set …
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed 14/set AHA EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Universal-ended leadwire set EUDAMEDVital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed,14 set/ AHA FDA UDI
- Model / Reference
- Universal-ended leadwire sets EUDAMED2089797-001 EUDAMEDFDA UDI
- Description
- Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed,14 set/ AHA FDA UDI
Identifiers
- Catalog Number
- 2089797-001 FDA UDI
- Primary DI / UDI-DI
- 10889483577516 EUDAMEDFDA UDI
- Basic UDI-DI
- 088948320041bDCAR9W EUDAMED
- Direct Marketing DI
- 10889483577516 EUDAMED
- 510(k) Number
- K082851 FDA UDI
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic lead set, reusable
Vital Signs™ Leadwire Set, Diagnostic Cardiology Universal-ended, Mixed 14/set … by AirLife Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 088948320041bDCAR9W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED a5d0e929-a74a-41b5-a6ed-eb171d831d44 61 fields · synced Jun 18, 2026
- FDA UDI 83db48f3-d7cc-4136-98ca-16a0a08eccdb 37 fields · synced May 29, 2026