Home GUDID 04719875599033 EpiFaith CV
Primary DI 04719875599033
Brand EpiFaith CV
Company Flat Medical Co., Ltd.
Model FM-11SLR
Catalog number FM-11SLR
Device description 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.
Published 2022-10-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name DQX Wire, Guide, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQX Wire, Guide, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14719875599030 Package GS1 25 In Commercial Distribution 04719875599033 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14719875599030 14719875599030 04719875599033 04719875599033 4719875599033
GMDN Terms# Term, Definition table Term Definition Central venous catheterization kit, short-term A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0
Regulatory Flags# DUNS number 656303754 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884450529300 SplashWire™ Merit Medical Systems, Inc. DQX 2026-08-21 00884450529713 SplashWire™ Merit Medical Systems, Inc. DQX 2026-08-21 00884450529829 SplashWire™ Merit Medical Systems, Inc. DQX 2026-08-21 00884450590010 SplashWire™ Merit Medical Systems, Inc. DQX 2026-08-21 00884450631928 InQwire® Amplatz Merit Medical Systems, Inc. DQX 2026-08-21 00884450731789 InQwire® Merit Medical Systems, Inc. DQX 2026-08-21 00884450739709 InQwire® Merit Medical Systems, Inc. DQX 2026-08-21 10801902226430 ARROW TELEFLEX INCORPORATED DQX 2026-08-10 10801902206241 ARROW TELEFLEX INCORPORATED DQX 2026-08-03 10801902192230 ARROW TELEFLEX INCORPORATED DQX 2026-08-01 04547327167215 CROSSLOOP ASAHI INTECC CO., LTD. DQX 2026-07-31 04547327167222 CROSSLOOP ASAHI INTECC CO., LTD. DQX 2026-07-31 04547327167239 CROSSLOOP ASAHI INTECC CO., LTD. DQX 2026-07-31 04547327167246 CROSSLOOP ASAHI INTECC CO., LTD. DQX 2026-07-31 04547327167253 CROSSLOOP ASAHI INTECC CO., LTD. DQX 2026-07-31 04547327167260 CROSSLOOP ASAHI INTECC CO., LTD. DQX 2026-07-31 10801902190908 ARROW TELEFLEX INCORPORATED DQX 2026-07-30 10801902198461 ARROW TELEFLEX INCORPORATED DQX 2026-07-30 10705032057004 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057011 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057028 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057035 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057042 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057059 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057066 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057073 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10705032057080 AQUATRACK™ Hydrophilic Nitinol Guidewire Cordis US Corp. DQX 2026-07-29 10801902193237 ARROW TELEFLEX INCORPORATED DQX 2026-07-29 10801902193244 ARROW TELEFLEX INCORPORATED DQX 2026-07-29 10801902195101 ARROW TELEFLEX INCORPORATED DQX 2026-07-29