FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kendall
DI: 20192253016830
·
Model: 30710001
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
75
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Basic Information
- Brand Name
- Kendall
- Primary DI
- 20192253016830
- Version / Model
- 30710001
- Catalog Number
- 30710001
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 4
- Public Version Date
- 2024-12-02
- Public Version Status
- Update
- Public Device Record Key
- c01905c5-b047-4c8d-88ee-564a13b9f9da
- Distribution End Date
- 2024-11-30
Device Description
Kendall Pe-wired Neonatal, Foam Monitoring electrode ( 3/PK)
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| 17460 | Neonatal electrocardiographic electrode | A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253016831 | GS1 | CASE | 4 | Not in Commercial Distribution | 2024-11-30 |
| Primary | 20192253016830 | GS1 | ||||
| Unit of Use | 10192253016833 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 12 – 32 Degrees Celsius