EpiFaith Syringe

GUDID 14719875599061

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 ID14719875599061
NIH Device Record Key43fa66b6-e761-468b-80da-219fc5399f50
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpiFaith Syringe
Version Model NumberFM-01SLL
Company DUNS656303754
Company NameFlat Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com
Phone+886225672959
Emailinfo@flatmedical.com

Device Dimensions

Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter
Length10.2 Centimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS104719875599064 [Primary]
GS114719875599061 [Package]
Contains: 04719875599064
Package: case [50 Units]
In Commercial Distribution
GS124719875599068 [Package]
Package: Transport carton [600 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-10
Device Publish Date2024-04-02

On-Brand Devices [EpiFaith Syringe]

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