FDA UDI
In Commercial Distribution
🇺🇸 United States
FlowSaver
DI: 00810123710546
·
Model: AS-01189/ 80-101
·
Inari Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FlowSaver
- Primary DI
- 00810123710546
- Version / Model
- AS-01189/ 80-101
- Catalog Number
- 80-101
- Company Name
- Inari Medical, Inc.
- Labeler DUNS
- 076827459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-29
- Public Version
- 3
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 7877ebaa-92b7-436f-bb6e-1d2707d3afb4
Device Description
FlowSaver
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 |
|---|---|---|---|---|
| CAC | Apparatus, Autotransfusion | Anesthesiology | 868.5830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35071 | Blood transfusion filter | A microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810123710546 | GS1 |
Customer Contacts
- Phone
- 18779234747
- [email protected]