FDA UDI
In Commercial Distribution
🇺🇸 United States
QuickClear
DI: 00845225003005
·
Model: P3223ASP
·
Volcano Atheromed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QuickClear
- Primary DI
- 00845225003005
- Version / Model
- P3223ASP
- Catalog Number
- P3223ASP
- Company Name
- Volcano Atheromed, Inc.
- Labeler DUNS
- 788341084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-11
- Public Version
- 7
- Public Version Date
- 2023-07-27
- Public Version Status
- Update
- Public Device Record Key
- a3828b8f-4660-4b8a-a3f4-198afe3cc401
Device Description
QuickClear Aspiration Pump
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 |
|---|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66528 | Thrombectomy electric suction pump, single-use | An electrically-powered pump designed specifically to aspirate clotted blood (e.g., thrombi, emboli), or other formed elements, from vessels of the arterial and venous systems to treat vascular obstruction and restore blood flow. It generates a negative pressure for aspiration and may be provided with collection containers, syringe and tubing; it is typically intended to be connected to a patient contact catheter (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845225003005 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193197 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight