Vital Signs
- Primary DI
- 10885403258275
- Brand
- Vital Signs
- Company
- Carefusion Finland 320 Oy
- Model
- 545327-HEL
- Catalog number
- 545327-HEL
- Device description
- 300-Series ECG Leadwire, 3-lead, Snap, AHA, 75 cm/ 30 in
- Published
- 2016-09-14
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MLD | MONITOR, ST SEGMENT WITH ALARM |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MLD | Monitor, St Segment With Alarm | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10885403258275 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10885403258275 | 10885403258275 |
GMDN Terms
| Term | Definition |
|---|
| Electrocardiographic lead set, reusable | A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -22 Degrees Fahrenheit | 140 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 367919120
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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