MF SAFECATH

Primary DI
28800055100412
Brand
MF SAFECATH
Company
Medifirst co., ltd.
Model
SS205
Catalog number
Intravascular catheter 20Gx1.88"
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
28800055100412PackageGS1200In Commercial Distribution
18800055100415PrimaryGS10
08800055100418Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880005510041228800055100412
1880005510041518800055100415
08800055100418088000551004188800055100418

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], 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 microcatheter for access into superselective small vessels. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688303694
Device count
50
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
false
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
18800055100293MF SAFECATHSC109"Intravascular catheter 16Gx1.16"""2020-08-10
18800055100309MF SAFECATHSC108"Intravascular catheter 18Gx1.88"""2020-08-10
18800055100316MF SAFECATHSC107"Intravascular catheter 18Gx1.25"""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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007208SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007215SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007222SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007239SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007253SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007284SOL CARE 1 DELTA MED SPAFOZ2021-03-30
08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005464Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005471Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005495Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26