FDA UDI
In Commercial Distribution
🇺🇸 United States
ECG Electrodes
DI: 00884838013452
·
Model: CBL ECG 5 LEAD GRABBER, IEC, TELE
·
Philips Medical Systems Hsg
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ECG Electrodes
- Primary DI
- 00884838013452
- Version / Model
- CBL ECG 5 LEAD GRABBER, IEC, TELE
- Catalog Number
- 989803171931
- Company Name
- Philips Medical Systems Hsg
- Labeler DUNS
- 790605856
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 7
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 57073d74-98f0-4b7a-a72f-29621eb5c9ca
Device Description
MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, IEC color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| DSI | DETECTOR AND ALARM, ARRHYTHMIA | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35562 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838013452 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity