FDA.reportPublic FDA data

NeoMagic

Primary DI
B339194416300
Brand
NeoMagic
Company
Neo Medical Inc.
Model
1944-1630
Catalog number
1944-1630
Device description
1.9Fr x 30cm Single Lumen PICC w/o Stylet
Published
2025-01-08
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
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953300000V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETERHdc Corp.1996-04-30LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B339194416305PackageHIBCC10In Commercial Distribution
B339194416300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge1.9French
Length30Centimeter

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
8884503334support@neomedicalinc.com

Regulatory Flags#

DUNS number
015510540
Device count
1
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
B33919570010NeoMagic1957-0011957-0012026-03-27
B33919580010NeoMagic1958-0011958-0012026-03-27
B33919580020V-Lock1958-0021958-0022026-03-27
B33919580050NeoMagic1958-0051958-0052026-03-27
B33919580060NeoMagic1958-0061958-0062026-03-27
B33919670010NeoMagic1967-0011967-0012026-03-27
B33919770010NeoMagic1977-0011977-0012026-03-27
B33919800010V-Cath1980-0011980-0012026-03-27
B339252526500NeoMagic2525-26502525-26502025-08-18
B339252526505NeoMagic2525-26502525-26502025-08-18
B339194316060NeoMagic1943-16061943-16062016-09-24
B339194316080NeoMagic1943-16081943-16082016-09-24
B339194316250NeoMagic1943-16251943-16252016-09-24
B339194316400NeoMagic1943-16401943-16402016-09-24
B339194416250NeoMagic1944-16251944-16252016-09-24
B339194416400NeoMagic1944-16401944-16402016-09-24
B339194416500NeoMagic1944-16501944-16502025-01-08
B339194616060NeoMagic1946-16061946-16062022-03-11
B339194616080NeoMagic1946-16081946-16082022-03-11
B339194616400NeoMagic1946-16401946-16402022-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
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H787MRC3R0001C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H787MRC3S910C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H787MRC3S960C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08
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H96560M0411550BioFloNAVILYST MEDICAL, INC.LJS2021-05-14
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