FDA.reportPublic FDA data

EpiFaith CV

Primary DI
04719875599033
Brand
EpiFaith CV
Company
Flat Medical Co., Ltd.
Model
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212615000EpiFaith CVFlat Medical Co., Ltd.2022-09-21DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719875599030PackageGS125In Commercial Distribution
24719875599037PackageGS1300In Commercial Distribution
04719875599033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987559903014719875599030
2471987559903724719875599037
04719875599033047198755990334719875599033

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA 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
TypeValueUnit
Length80Millimeter

Contacts#

Phone, Email table
PhoneEmail
+886225672959shaowei@flatmedical.com

Regulatory Flags#

DUNS number
656303754
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719875599064EpiFaith SyringeFM-01SLL2024-04-02
14719875599061EpiFaith SyringeFM-01SLL2024-04-02
04719875599019EpiFaith SyringeFM-01SLR2020-07-07
04719875599026EpiFaith SyringeFM-02SNR2020-07-07
14719875599016EpiFaith SyringeFM-01SLR2020-07-07
14719875599023EpiFaith SyringeFM-02SNR2020-07-07
14719875599030EpiFaith CVFM-11SLR2022-10-26
44719875599017EpiFaith SyringeFM-01SLR2020-07-07
44719875599024EpiFaith SyringeFM-02SNR2020-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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