FDA.reportPublic FDA data

EpiFaith CV

Primary DI
14719875599030
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
656303754
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04719875599033EpiFaith CVFM-11SLR2022-10-26
14719875599016EpiFaith SyringeFM-01SLR2020-07-07
14719875599023EpiFaith SyringeFM-02SNR2020-07-07
44719875599017EpiFaith SyringeFM-01SLR2020-07-07
44719875599024EpiFaith SyringeFM-02SNR2020-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
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07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
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07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
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