FDA.reportPublic FDA data

NAMIC

Primary DI
H965640001220
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
64000122
Device description
Y-Adaptor
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
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900652000NAMIC PTCA Y-ADAPTORNorth American Instrument Corp.1990-06-26DTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965640001221PackageHIBCC5In Commercial Distribution
H965640001220PrimaryHIBCC0

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
Lumen/Inner Diameter0.1Inch

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
H787LG191005LifeguardLG-19-1002016-09-20
H787LG19755LifeguardLG-19-752016-09-20
H787LG201005LifeguardLG-20-1002016-09-20
H787LG201505LifeguardLG-20-1502016-09-20
H787LG20505LifeguardLG-20-502016-09-20
H787LG20755LifeguardLG-20-752016-09-20
H787LG221005LifeguardLG-22-1002016-09-20
H787LG22505LifeguardLG-22-502016-09-20
H787LG22755LifeguardLG-22-752016-09-20
H787LPS30045LifeportLPS 30042016-09-20
H787LPS30055LifeportLPS 30052016-09-20
H787LPS30065LifeportLPS 30062016-09-20
H787LPS30075LifeportLPS 30072016-09-20
H787LPS30085LifeportLPS 30082016-09-20
H787LPS30095LifeportLPS 30092016-09-20
H787LPS30175LifeportLPS 30172016-09-20
H787LPS30235LifeportLPS 30232016-09-20
H787LPS30255LifeportLPS 30252016-09-20
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489059199NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489064520NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489059151NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059175NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064506NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064537NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059144NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059168NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059182NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064483NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064490NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064513NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064544NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064551NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064568NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064575NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489058819NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058840NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058857NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058864NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058871NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058932NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058949NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058970NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
H965814001240NAMICANGIODYNAMICS, INC.DTL2020-11-03
07613327459210AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459180AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459197AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08