FDA UDI
In Commercial Distribution
🇺🇸 United States
3-LD DIN ECG CABLE,A,90 DEG MON. END
DI: 00840828161091
·
Model: CB-71320R/90
·
CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3-LD DIN ECG CABLE,A,90 DEG MON. END
- Primary DI
- 00840828161091
- Version / Model
- CB-71320R/90
- Catalog Number
- 5478
- Company Name
- CURBELL MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 796452311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-08
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- b0893128-e036-4c8a-9edd-dd6d15b86cdf
Device Description
3-LD DIN ECG CABLE,A,90 DEG MON. END
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 |
|---|---|---|---|---|
| 60635 | Electrocardiographic electrode connector | A small clip designed to enable an electrical connection between an electrocardiographic electrode and an electrocardiographic lead wire. It is typically made of plastic materials, with a metallic part to provide electrical connection, and can be manually applied to a dedicated area of a disk-like electrode that is placed on the patient’s skin, with a socket at the other end for a plug on the lead. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840828161091 | GS1 |
Customer Contacts
- Phone
- 1-800-235-7500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081762 | 000 |