EpiFaith CV

GUDID 14719875599030

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.

FLAT MEDICAL CO., LTD.

Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term

• Primary Device ID: 14719875599030
• NIH Device Record Key: 0b9e72c2-8c70-4daa-8412-32329ee8a7da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpiFaith CV
• Version Model Number: FM-11SLR
• Company DUNS: 656303754
• Company Name: FLAT MEDICAL CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com
• Phone: +886225672959
• Email: shaowei@flatmedical.com

Device Dimensions

• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719875599033 [Primary]
GS1	14719875599030 [Package]; Contains: 04719875599033; Package: Carton [25 Units]; In Commercial Distribution
GS1	24719875599037 [Package]; Package: Box [300 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212615

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-03
• Device Publish Date: 2022-10-26

Devices Manufactured by FLAT MEDICAL CO., LTD.

• 14719875599061 - EpiFaith Syringe: 2024-04-10 EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verif
• 14719875599016 - EpiFaith Syringe: 2023-02-09 EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verif
• 14719875599023 - EpiFaith Syringe: 2023-02-09 EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verif
• 14719875599030 - EpiFaith CV: 2022-11-03The 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.
• 14719875599030 - EpiFaith CV: 2022-11-03 The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-as
• 44719875599017 - EpiFaith Syringe: 2020-07-15 EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verif
• 44719875599024 - EpiFaith Syringe: 2020-07-15 EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verif