FDA UDI
In Commercial Distribution
🇺🇸 United States
SURE LOCK, ASSEMBLY, A34, ORANGE LEVER
DI: 00840828187350
·
Model: SLC-4200-004
·
CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SURE LOCK, ASSEMBLY, A34, ORANGE LEVER
- Primary DI
- 00840828187350
- Version / Model
- SLC-4200-004
- Catalog Number
- 27757
- Company Name
- CURBELL MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 796452311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-09
- Public Version
- 1
- Public Version Date
- 2023-01-17
- Public Version Status
- New
- Public Device Record Key
- dd7dd733-bba5-4eb4-858e-803e73c43afc
Device Description
SURE LOCK, ASSEMBLY, A34, ORANGE LEVER
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 00840828187404 | GS1 | BAG | 10 | In Commercial Distribution | |
| Primary | 00840828187350 | GS1 | ||||
| Package | 00840828187411 | GS1 | BAG | 14 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-235-7500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080605 | 000 |