Identity
- Trade Name
- FLO30™ FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Model / Reference
- 00884450635827 FDA UDI
Identifiers
- Catalog Number
- 1119-001 FDA UDI
- Primary DI / UDI-DI
- 00884450635827 FDA UDI
- FDA Product Code
- OEQ FDA UDI
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemostasis valve
A comprehensive, non-invasive vasculature device designed as a conduit through which small-diameter diagnostic/interventional devices can be introduced into or withdrawn from patients' vasculature while preventing backflow of blood. It is intended for urinary applications and may include noninvasive guidewire accessories.
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Also classified as Haemostasis valve.
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- AVANTI — Cordis Corp. · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 4e7b569f-37cc-4518-ba0b-1d50285d3d68 33 fields · synced Jul 17, 2026