FDA.reportPublic FDA data

Lyka® PORT Needle Free Access Device

Primary DI
00634624417021
Brand
Lyka® PORT Needle Free Access Device
Company
QUEST MEDICAL INC
Model
4170Y
Published
2025-06-12
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241058000Lyka® PORT Needle Free Access Device (4170Y)Quest Medical, Inc.2024-12-18FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10634624417028PackageGS150In Commercial Distribution
20634624417025PackageGS14In Commercial Distribution
00634624417021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063462441702810634624417028
2063462441702520634624417025
00634624417021006346244170216346244170210634624417021

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis tubing valve-connectorA small, sterile, stand-alone, Luer-activated plastic valve intended to be connected to a haemodialysis catheter to allow external tubing to be connected to the catheter in a secure, sealed, locked position until disconnection of the tubing, whereupon it is designed to seal the catheter (i.e., between haemodialysis therapies). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 800-627-0226custserv@questmedical.com

Regulatory Flags#

DUNS number
041810693
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
00634624530485MPS® 3 Console Pole Mount Plate530102453010242026-07-20
006346240906516" (15 cm) Microbore Extension Set with Clamp90652017-02-13
006346240925017 in (18cm) Y-Extension Set w/ 2 check valves925092502016-07-26
0063462409541044 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site954195412016-07-26
00634624095434Q2 Checkmate Extension Set95432016-06-10
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624621015Precision Delivery IV Extension SetPD602021-02-05
00634624621022Precision Delivery IV Extension SetPD60F2021-02-05
00634624621039Precision Delivery IV Extension SetPDM602021-02-05
00634624621046Precision Delivery IV Extension SetPDM60F2021-02-05
00634624621053Precision Delivery IV Extension SetPDMV602021-02-05
00634624621060Precision Delivery IV Extension SetPDMV60F2021-02-05
00634624621077Precision Delivery IV Extension SetPDV062021-02-05
00634624621084Precision Delivery IV Extension SetPDV06F2021-02-05
00634624621091Precision Delivery IV Extension SetPDV602021-02-05
00634624621107Precision Delivery IV Extension SetPDV60F2021-02-05
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05

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