FDA UDI
In Commercial Distribution
🇺🇸 United States
MR Patient Care Long Wide ECG 2.0 Cable AAMI
DI: 00884838102378
·
Model: Long Wide ECG 2.0 Cable AAMI
·
Philips Ds North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MR Patient Care Long Wide ECG 2.0 Cable AAMI
- Primary DI
- 00884838102378
- Version / Model
- Long Wide ECG 2.0 Cable AAMI
- Catalog Number
- 989803170121
- Company Name
- Philips Ds North America LLC
- Labeler DUNS
- 013649151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-13
- Public Version
- 5
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 37aed5d1-b773-441f-95e6-a0d7b25344c9
Device Description
ECG Leadwire Set designed for use with the Expression MRI Patient Monitor when utlizing the system's Advanced ECG Gradient Filter. Compatible with the CV Quadtrode 9371A.
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
- No
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | Cardiovascular | 870.2300 | 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 | 00884838102378 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 570 – 1020 millibar
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 102 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 429 – 765 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 80 Percent (%) Relative Humidity