FDA.reportPublic FDA data

V-Cath

Primary DI
B3393903000
Brand
V-Cath
Company
Neo Medical Inc.
Model
390-300
Catalog number
390-300
Device description
5.0Fr (15ga) Sharps Safety Tearaway Sheath Introducer
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K022099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022099000SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'SHdc Corp.2002-09-20FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3393903005PackageHIBCC10In Commercial Distribution
B3393903000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Needle Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Sunlight
Special Storage Condition, Specify00Keep Dry

Regulatory Flags#

DUNS number
015510540
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B33919580040NeoMagic1958-0041958-0042016-09-24
B33920964000NeoMagic2096-4002096-4002016-09-24
B3393000080NeoMagic300-008300-0082016-09-24
B33930290030NeoMagic3029-0033029-0032016-09-24
B33930530030NeoMagic3053-0033053-0032016-09-24
B33930580040NeoMagic3058-0043058-0042016-09-24
B339350250NeoMagic350-25350-252016-09-24
B3393503000NeoMagic350-300350-3002016-09-24
B33935290030NeoMagic3529-0033529-0032025-01-22
B339360250V-Cath360-25360-252016-09-24
B3393603000NeoMagic360-300360-3002016-09-24
B339380250V-Cath380-25380-252016-09-24
B3393803000V-Cath380-300380-3002016-09-24
B339390250V-Cath390-25390-252016-09-24
B3394000080V-Cath400-008400-0082016-09-24
B33940290030V-Cath4029-0034029-0032016-09-24
B33940530030V-Cath4053-0034053-0032016-09-24
B3395000080V-Cath500-008500-0082016-09-24
B33950290030V-Cath5029-0035029-0032016-09-24
B33950530030V-Cath5053-0035053-0032016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
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