gudid
Primary ID: FM-11SLR
EpiFaith CV (UDI FM-11SLR)
Manufactured by Flat Medical Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for EpiFaith CV - Primary ID FM-11SLR
Device Regulatory Overview
The EpiFaith CV (Model/Catalog Number: FM-11SLR) is a medical device manufactured by Flat Medical Co., Ltd.. This product is indexed under FDA Product Code / Category Classification DQX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FM-11SLR
- Product Code / EMDN
- DQX
- Device Name
- The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025" (0.64 mm) to 0.038"(0.96 mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population.
- Database Sync Date
- 2026-08-09 09:46:09
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of EpiFaith CV?
The registered manufacturer of record for EpiFaith CV is Flat Medical Co., Ltd..
What is the Primary UDI-DI identifier for EpiFaith CV?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FM-11SLR.
What classification code is assigned to this device?
This device is registered under product classification code DQX.
Similar Classification Devices (DQX)
Other Devices by Flat Medical Co., Ltd.
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