FDA.reportPublic FDA data

NAMIC

Primary DI
H965700153120
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
70015312
Device description
EXTENSION SET
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790082000ARTERIAL EXTENSION SETNamic1979-01-25DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965700153121PackageHIBCC25In Commercial Distribution
H965700153120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Inch
Pressure200Pound per Square Inch

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
809699023
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29
H787CT50LPBDNFVI0BioFlo VortexCT50LPBDNFVI2020-05-29
H787CT50LPBDVI0BioFlo VortexCT50LPBDVI2020-05-29
H787CT50LTBANFVI0BioFlo VortexCT50LTBANFVI2020-05-29
H787CT50LTBAVI0BioFlo VortexCT50LTBAVI2020-05-29
H787CT50LTBDNFVI0BioFlo VortexCT50LTBDNFVI2020-05-29
H787CT50LTBDVI0BioFlo VortexCT50LTBDVI2020-05-29
H787CT50PTBANFVI0BioFlo VortexCT50PTBANFVI2020-05-29
H787CT50PTBAVI0BioFlo VortexCT50PTBAVI2020-05-29
H787CT50PTBDNFVI0BioFlo VortexCT50PTBDNFVI2020-05-29
H787CT50PTBDVI0BioFlo VortexCT50PTBDVI2020-05-29
H787CT50STBDNFVI0BioFlo VortexCT50STBDNFVI2020-05-29
H787CT50STBDVI0BioFlo VortexCT50STBDVI2020-05-29
H787CT60LPBANFVI0BioFlo VortexCT60LPBANFVI2020-05-29
H787CT60LPBAVI0BioFlo VortexCT60LPBAVI2020-05-29
H787CT60LPBDNFVI0BioFlo VortexCT60LPBDNFVI2020-05-29
H787CT60LPBDVI0BioFlo VortexCT60LPBDVI2020-05-29
H787CT60LPPANFNV0BioFlo VortexCT60LPPANFNV2020-05-29
H787CT60LPPANFVI0BioFlo VortexCT60LPPANFVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213208Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213369Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213666Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213741Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213888Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213918Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214007Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214083Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214120Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214168Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214243Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214342Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214380Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214441Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214472Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214502Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214632Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214656Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214663Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24