EpiFaith Syringe

GUDID 14719875599023

EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

Flat Medical Co., Ltd.

Low-resistance epidural syringe

• Primary Device ID: 14719875599023
• NIH Device Record Key: b02a71a9-8cb9-457e-ace6-27ba414fa8f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpiFaith Syringe
• Version Model Number: FM-02SNR
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719875599026 [Primary]
GS1	14719875599023 [Package]; Contains: 04719875599026; Package: case [50 Units]; In Commercial Distribution
GS1	54719875599021 [Package]; Package: Transport carton [600 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192421

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-02-09
• Device Publish Date: 2020-07-07

On-Brand Devices [EpiFaith Syringe]

• 44719875599024: EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance,
• 44719875599017: EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance,
• 14719875599023: EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance,
• 14719875599016: EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance,
• 14719875599061: EpiFaith Syringe is intended for use with an epidural needle for detecting a loss of resistance,