FDA UDI
In Commercial Distribution
🇺🇸 United States
Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets
DI: 20884838114078
·
Model: 5-LEAD SET, DISPOSABLE, CHEST, AAMI
·
Philips Medical Systems Hsg
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- Single-Patient-Use Disposable ECG 3, 5, 6 Lead Sets
- Primary DI
- 20884838114078
- Version / Model
- 5-LEAD SET, DISPOSABLE, CHEST, AAMI
- Catalog Number
- 989803192141
- Company Name
- Philips Medical Systems Hsg
- Labeler DUNS
- 790605856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-09-16
- Public Version
- 2
- Public Version Date
- 2025-12-03
- Public Version Status
- Update
- Public Device Record Key
- f7b41bb4-1936-497b-a390-38636c351cb5
Device Description
5-Lead Set, disposable chest leads for single patient use, to measure 12-lead bedside ECG. AAMI color coded grabbers. Round peelable ribbon style wires. Wirelength: 3.3ft (1m). For use with trunk cables: M1663A and M1949A when paired with 989803173131 (disposable limb leads). 1 Sales Unit = 20 individually packagedlead sets.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61821 | Electrocardiographic lead set, single-use | A collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00884838114074 | GS1 | ||||
| Primary | 20884838114078 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 10 – 108 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity