FDA UDI
In Commercial Distribution
🇺🇸 United States
LDW, 5 LEAD, PINCH, INTELLIVUE, 40", AHA
DI: 90840828157172
·
Model: DLA-05BK-40AS-0000
·
CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LDW, 5 LEAD, PINCH, INTELLIVUE, 40", AHA
- Primary DI
- 90840828157172
- Version / Model
- DLA-05BK-40AS-0000
- Catalog Number
- 18121
- Company Name
- CURBELL MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 796452311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-31
- Public Version
- 1
- Public Version Date
- 2019-08-08
- Public Version Status
- New
- Public Device Record Key
- aef689f0-fe45-41da-ad57-1146c8b21b7b
Device Description
LDW, 5 LEAD, PINCH, INTELLIVUE, 40", AHA
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 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 |
|---|---|---|---|---|---|---|
| Primary | 90840828157172 | GS1 | ||||
| Package | 90840828173851 | GS1 | 10 | In Commercial Distribution | ||
| Package | 90840828173844 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-235-7500
- [email protected]