FDA UDI
In Commercial Distribution
🇺🇸 United States
patient lead wire
DI: 00884838117211
·
Model: Long Complete Lead Set AAMI
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- patient lead wire
- Primary DI
- 00884838117211
- Version / Model
- Long Complete Lead Set AAMI
- Catalog Number
- 989803151651
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-16
- Public Version
- 1
- Public Version Date
- 2026-01-26
- Public Version Status
- New
- Public Device Record Key
- 50a4c762-e180-4f72-b8f3-86aecafa8d63
Device Description
Long complete lead set for PageWriter TC Series Cardiographs, AAMI color coded. Consisting of 2 long arm leads (54" (1,37m)), 2 long leg leads (56" (1,42m)), 2 long 1 into 3 Trident leads (42" (1,07m)), 2 lead separators, 2.54 DIA, 2 Trident Yoke labels (V1-V3, V4-V6), 4 colered clips, 14x colored rings, 6 brown base rings and instructions for use. This lead set comes fully assembled. 1complete lead set = 1 sales unit
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
- 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 |
|---|---|---|---|---|
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35562 | Electrocardiographic lead set, reusable | 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 (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 | 00884838117211 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius