EpiFaith Syringe

GUDID 44719875599024

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 syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe Low-resistance syringe
Primary Device ID44719875599024
NIH Device Record Keyb02a71a9-8cb9-457e-ace6-27ba414fa8f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpiFaith Syringe
Version Model NumberFM-02SNR
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 Latextrue
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
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

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
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
GS134719875599027 [Primary]
GS144719875599024 [Package]
Contains: 34719875599027
Package: box [50 Units]
In Commercial Distribution
GS154719875599021 [Package]
Package: Transport carton [600 Units]
In Commercial Distribution
GS164719875599028 [Package]
Contains: 34719875599027
Package: box [10 Units]
In Commercial Distribution
GS174719875599025 [Package]
Contains: 64719875599028
Package: Transport carton [120 Units]
In Commercial Distribution
GS184719875599022 [Package]
Contains: 34719875599027
Package: Transport carton [300 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 Date2020-07-15
Device Publish Date2020-07-07

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,
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.