FDA UDI
In Commercial Distribution
🇺🇸 United States
Kendall
DI: 20192253020141
·
Model: EP30016
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
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Basic Information
- Brand Name
- Kendall
- Primary DI
- 20192253020141
- Version / Model
- EP30016
- Catalog Number
- EP30016
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 3
- Public Version Date
- 2026-01-22
- Public Version Status
- Update
- Public Device Record Key
- ed3c4a68-94bc-4a6b-8906-e4c37f506f1f
Device Description
L36-LB CLOTH LIMB BAND NEONATAL ELECTRODES Prewired
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
- MR Unsafe
- 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 | 50192253020142 | GS1 | CASE | 100 | In Commercial Distribution | |
| Primary | 20192253020141 | GS1 | ||||
| Unit of Use | 10192253017854 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 12 – 32 Degrees Celsius