FDA UDI
In Commercial Distribution
🇺🇸 United States
EKG CABLE, 10 LEAD, COMPATIBLE TO MAC 1100,1200,1200ST, BANANA PLUG
DI: 00840828110426
·
Model: CB-45509-B
·
CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EKG CABLE, 10 LEAD, COMPATIBLE TO MAC 1100,1200,1200ST, BANANA PLUG
- Primary DI
- 00840828110426
- Version / Model
- CB-45509-B
- Catalog Number
- 5458
- Company Name
- CURBELL MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 796452311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-15
- Public Version
- 4
- Public Version Date
- 2021-06-30
- Public Version Status
- Update
- Public Device Record Key
- 958604eb-9233-4f92-b057-f35a7b03b4b3
Device Description
EKG CABLE, 10 LEAD, COMPATIBLE TO MAC 1100,1200,1200ST, BANANA PLUG
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42489 | Electrocardiographic electrode, reusable | A 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, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840828110426 | GS1 |
Customer Contacts
- Phone
- 1-800-235-7500
- [email protected]