FDA UDI
In Commercial Distribution
🇺🇸 United States
Trulink
DI: 10841522124662
·
Model: ECG Cables & Leadwires
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trulink
- Primary DI
- 10841522124662
- Version / Model
- ECG Cables & Leadwires
- Catalog Number
- 700-1008-12
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-07
- Public Version
- 1
- Public Version Date
- 2024-06-17
- Public Version Status
- New
- Public Device Record Key
- bdcaa8e7-efc1-41c9-80a2-a0a82e3fffc2
Device Description
CABLE,ECG,UN-SHLD,NEO,3-LEAD,305CM/10 FT,AAMI
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSI | DETECTOR AND ALARM, ARRHYTHMIA | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42489 | Electrocardiographic electrode, reusable | A noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841522124662 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103142 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 305 cm/10 ft length |