FDA UDI
In Commercial Distribution
🇺🇸 United States
Solvent Medical
DI: 00862412000203
·
Model: 649
·
SOLVENT MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Solvent Medical
- Primary DI
- 00862412000203
- Version / Model
- 649
- Company Name
- SOLVENT MEDICAL, LLC
- Labeler DUNS
- 080412225
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-02
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8599a476-7a22-4489-bc25-04be0c7dcc2b
Device Description
Disposable Temporary Pacing Cable
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 47483 | Electrocardiographic lead/catheter adaptor | A small, sterile, connecting device that enables a mechanical union between an in situ cardiac catheter [e.g., an electrophysiology (EP) diagnostic catheter] and an electrocardiograph (ECG) cable/lead for transmission of heart signals to an ECG machine. This device allows the connection of the otherwise incompatible connectors of the cardiac catheter to a standard ECG cable/lead or a cable/lead of different manufacture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20862412000207 | GS1 | Case | 50 | In Commercial Distribution | |
| Package | 10862412000200 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00862412000203 | GS1 |
Customer Contacts
- Phone
- 404-696-6999
- [email protected]