FDA UDI
In Commercial Distribution
🇺🇸 United States
Large Bore 60 cc Syringe
DI: 00850291007697
·
Model: 99-102
·
Inari Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Large Bore 60 cc Syringe
- Primary DI
- 00850291007697
- Version / Model
- 99-102
- Catalog Number
- 99-102
- Company Name
- Inari Medical, Inc.
- Labeler DUNS
- 076827459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-20
- Public Version
- 3
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 68cb3834-6842-42d3-b143-90bf3867199b
Device Description
Large Bore 60 cc Syringe
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 |
|---|---|---|---|---|
| DXE | Catheter, Embolectomy | Cardiovascular | 870.5150 | 2 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | 870.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65282 | Thrombectomy manual aspirator | A manually-powered, syringe-like device 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. The device plunger is withdrawn by the user to generate a negative pressure for aspiration, and collection containers and tubing may be included; it is typically intended to be connected to a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 | 00850291007697 | GS1 | ||||
| Previous | 00850291007178 | GS1 |
Customer Contacts
- Phone
- 18779234747
- [email protected]