FDA.reportPublic FDA data

NAMIC

Primary DI
H965814001240
Brand
NAMIC
Company
ANGIODYNAMICS, INC.
Model
81400124
Device description
"Y-ADAPTOR,LG.BORE,FINE THREAD W/10"" FLEXCIL EXT.-OEM"
Published
2020-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
H965814001240PrimaryHIBCC0

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 Diameter0.113Inch

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23
05051684018503LifeportH787LPS30070LPS30072026-06-23
05051684018510LifeportH787LPS30080LPS30082026-06-23
05051684018527LifeportH787LPS30090LPS30092026-06-23
05051684018534LifeportH787LPS30170LPS30172026-06-23
05051684018541LifeportH787LPS30230LPS30232026-06-23
05051684018558LifeportH787LPS30250LPS30252026-06-23
05051684018565LifeguardH787LG191000LG-19-1002026-06-23
05051684018572LifeguardH787LG19750LG-19-752026-06-23
05051684018589LifeguardH787LG201000LG-20-1002026-06-23
05051684018596LifeguardH787LG201500LG-20-1502026-06-23
05051684018602LifeguardH787LG20500LG-20-502026-06-23
05051684018619LifeguardH787LG20750LG-20-752026-06-23
05051684018626LifeguardH787LG221000LG-22-1002026-06-23
05051684018633LifeguardH787LG22500LG-22-502026-06-23
05051684018640LifeguardH787LG22750LG-22-752026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10193489058949NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
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