FDA.reportPublic FDA data

MF SAFECATH

Primary DI
18800055100316
Brand
MF SAFECATH
Company
Medifirst co., ltd.
Model
SC107
Catalog number
"Intravascular catheter 18Gx1.25"""
Published
2020-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192230000MF SAFECATHMedifirst Co., Ltd.2020-04-23FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28800055100313PackageGS1200In Commercial Distribution
18800055100316PrimaryGS10
08800055100319Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880005510031328800055100313
1880005510031618800055100316
08800055100319088000551003198800055100319

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Regulatory Flags#

DUNS number
688303694
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18800055100293MF SAFECATHSC109"Intravascular catheter 16Gx1.16"""2020-08-10
18800055100309MF SAFECATHSC108"Intravascular catheter 18Gx1.88"""2020-08-10
18800055100323MF SAFECATHSC106"Intravascular catheter 18Gx1.16"""2020-08-10
18800055100330MF SAFECATHSC105"Intravascular catheter 20Gx1.88"""2020-08-10
18800055100347MF SAFECATHSC104"Intravascular catheter 20Gx1.25"""2020-08-10
18800055100354MF SAFECATHSC103"Intravascular catheter 20Gx1.16"""2020-08-10
18800055100361MF SAFECATHSC102"Intravascular catheter 22Gx1"""2020-08-10
18800055100378MF SAFECATHSC101"Intravascular catheter 24Gx0.75"""2020-08-10
18800055100385MF SAFECATHSS208"Intravascular catheter 18Gx1.88"""2020-08-10
18800055100392MF SAFECATHSS207"Intravascular catheter 18Gx1.25"""2020-08-10
18800055100408MF SAFECATHSS206"Intravascular catheter 18Gx1.16"""2020-08-10
18800055100415MF SAFECATHSS205"Intravascular catheter 20Gx1.88"""2020-08-10
18800055100422MF SAFECATHSS204"Intravascular catheter 20Gx1.25"""2020-08-10
18800055100439MF SAFECATHSS203"Intravascular catheter 20Gx1.16"""2020-08-10
18800055100446MF SAFECATHSS202"Intravascular catheter 22Gx1"""2020-08-10
18800055100453MF SAFECATHSS201"Intravascular catheter 24Gx0.75"""2020-08-10
18800055100460MF SAFECATHSC110"Intravascular catheter 16Gx1.77"""2020-08-10
28800055100290MF SAFECATHSC109Intravascular catheter 16Gx1.16"2020-08-10
28800055100306MF SAFECATHSC108Intravascular catheter 18Gx1.88"2020-08-10
28800055100313MF SAFECATHSC107Intravascular catheter 18Gx1.25"2020-08-10

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