FDA.reportPublic FDA data

Y CONNECTOR KIT

Primary DI
00850004162057
Brand
Y CONNECTOR KIT
Company
VALFLUX GROUP, LLC
Model
VGYCK113F
Catalog number
VGYCK113F
Device description
VGYCK113F Y CONNECTOR KIT
Published
2018-12-19
Public version status
New
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
K170024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170024000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004162057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004162057008500041620578500041620570850004162057

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+556230916442regulacao@valflux.com.br

Regulatory Flags#

DUNS number
050193715
Device count
1
Kit
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004162217SELDINGER NEEDLEVGSN03VGSN032018-12-19
00850004162224SELDINGER NEEDLEVGSN03AVGSN03A2018-12-19
00850004162231SELDINGER NEEDLEVGSN06VGSN062018-12-19
00850004162125INTRODUCER SETVGCTR03VGCTR032018-12-20
00850004162132INTRODUCER SETVGCTR03AVGCTR03A2018-12-20
00850004162149INTRODUCER SETVGCTR04VGCTR042018-12-20
00850004162156INTRODUCER SETVGCTR04AVGCTR04A2018-12-20
00850004162163INTRODUCER SETVGHIS00VGHIS002018-12-20
00850004162170INTRODUCER SETVGHIS01VGHIS012018-12-20
00850004162187INTRODUCER SETVGHIS02VGHIS022018-12-20
00850004162194INTRODUCER SETVGHIS03VGHIS032018-12-20
00850004162200INTRODUCER SETVGHIS04VGHIS042018-12-20
00850004162248TRANSRADIAL PRESSURE BANDAGEVGPB04AVGPB04A2018-12-19
00850004162255TRANSRADIAL PRESSURE BANDAGEVGPB04BVGPB04B2018-12-19
00850004162019MANIFOLDVGAM0201VGAM02012018-12-19
00850004162026MANIFOLDVGAM0301VGAM03012018-12-19
00850004162033MANIFOLDVGAM0401VGAM04012018-12-19
00850004162040INFLATION DEVICEVGAI25CVGAI25C2018-12-19
00850004162064HIGH PRESSURE TUBINGVGPMT0501VGPMT05012018-12-18
00850004162071HIGH PRESSURE TUBINGVGPMT0502VGPMT05022018-12-18

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