FDA.reportPublic FDA data

V-Cath

Primary DI
B33950291620
Brand
V-Cath
Company
Neo Medical Inc.
Model
5029-162
Catalog number
5029-162
Device description
5.0Fr x 20cm Single Lumen Midline with MST
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K983916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983916000V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)Hdc Corp.1998-11-23FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B33950291625PackageHIBCC10In Commercial Distribution
B33950291620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous catheterization kit, non-sensingA collection of non-powered devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French
Length20Centimeter

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
888-450-3334support@neomedicalinc.com

Regulatory Flags#

DUNS number
015510540
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
B3393903000V-Cath390-300390-3002016-09-24
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

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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10801902131178ARROWTELEFLEX INCORPORATEDFOZ2017-01-13
10801902130898ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130904ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130911ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130928ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
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10801902129359ARROWTELEFLEX INCORPORATEDFOZ2016-11-11