Identity
- Trade Name
- TRULINK FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- LDWR,SNAP,DIN,BROWN,61CM /24IN,AAMI,3/PK FDA UDI
- Model / Reference
- ECG Cables & Leadwires FDA UDI
- Description
- LDWR,SNAP,DIN,BROWN,61CM /24IN,AAMI,3/PK FDA UDI
Identifiers
- Catalog Number
- 012-0295-46 FDA UDI
- Primary DI / UDI-DI
- 10841522101519 FDA UDI
- 510(k) Number
- K983996 FDA UDI
- FDA Product Code
- MHX 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
Trulink by Spacelabs Healthcare (washington), 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
K983996 also covers:
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- TRULINK — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultralite — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultralite — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultralite — SPACELABS HEALTHCARE (WASHINGTON), 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
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI c9046be4-05fc-43ef-9736-c5dd0928f349 36 fields · synced May 30, 2026