FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH
DI: 00885380048473
·
Model: EPP3CR
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CARDINAL HEALTH
- Primary DI
- 00885380048473
- Version / Model
- EPP3CR
- Catalog Number
- EPP3CR
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 6
- Public Version Date
- 2018-12-31
- Public Version Status
- Update
- Public Device Record Key
- 4d0374cf-98a4-471c-8c01-798568aff95d
- Distribution End Date
- 2018-12-31
Device Description
Monitoring Electrode, Neonatal, Prewired, Cloth
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRX | Electrode, electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20885380048477 | GS1 | BOX | 300 | Not in Commercial Distribution | 2018-12-31 |
| Primary | 00885380048473 | GS1 | ||||
| Package | 50885380048478 | GS1 | CASE | 10 | Not in Commercial Distribution | 2018-12-31 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053011 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius