FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SOLOPATH
DI: 00389701012292
·
Model: SR-2425
·
TERUMO MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SOLOPATH
- Primary DI
- 00389701012292
- Version / Model
- SR-2425
- Catalog Number
- SR-2425
- Company Name
- TERUMO MEDICAL CORPORATION
- Labeler DUNS
- 131489882
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-17
- Public Version
- 3
- Public Version Date
- 2020-03-12
- Public Version Status
- Update
- Public Device Record Key
- 80b21178-667f-4e56-8712-690216cb06ac
- Distribution End Date
- 2019-11-15
Device Description
SOLOPATH Re-collapsible Access System
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | INTRODUCER, CATHETER | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50389701012297 | GS1 | Carton | 39 | Not in Commercial Distribution | 2019-11-15 |
| Primary | 00389701012292 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25 | Centimeter | |
| Device Size Text, specify | Inner Diameter: 24 FrenchOuter Diameter: 28.5 French | ||
| Device Size Text, specify | Nominal Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store at extreme temperature and humidity