Prelude® 10884450614942
by Merit Medical Systems, Inc.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Overview
The Prelude device from Merit Medical Systems, Inc. is a single-use vascular catheter introduction set designed for the safe and effective insertion of percutaneous vascular access devices into the vascular system. This device features a non-steerable introducer sheath with an inner obturator/dilator, along with additional access devices that may include a haemostatic valve to control blood loss. The Prelude device is intended for use in clinical settings where manual insertion and manipulation of these devices are challenging or impossible.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884450614942 | Date18 Mar 2022 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Prelude®
- Generic name
- Vascular catheter introduction set, nonimplantable
- Model / Ref / Catalog
- 10884450614942, PSI-6F-11-018NT4/D
- Primary DI / UDI-DI
- 10884450614942
- FDA product code
- DRE
- GMDN term
- Vascular catheter introduction set, nonimplantable
- Device class
- Class II
- Regulation number
- 870.1310
- GUDID distribution status
- In Commercial Distribution
Other devices from Merit Medical Systems, Inc.
Properties
Other properties (10)
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Prescription use: No
- Over-the-counter: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No