Yukon Medical, LLC

FDA Device Registration & Listing · Durham, NC, US · Registration 3009631669

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009631669
FEI Number
3009631669
Entity Name
Yukon Medical, LLC
City/State/Country
Durham, NC, US
Establishment Address
4021 Stirrup Creek Dr Ste 200, Durham, NC 27703, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Yukon Medical, LLC (Owner Number: 10041722)
Owner / Operator Contact Address
4021 Stirrup Creek Drive, Suite 200, Durham, NC 27703, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K120799
PMA Number
N/A

All Registered Proprietary Names

Arisure Closed System Drug Transfer Device (CSTD) ClearTip Swab Contoured Mini NB ClearTip Swab Contoured Mini ClearTip Swab Contoured ClearTip Ultra Thin Swab

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2021-06-13
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-12-13
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2020-10-21
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-04-02
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2015-09-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-11-20
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2017-11-20
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-10-23
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2017-11-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Yukon Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243985 Icu Medical, Inc. Rio™ Drug Reconstitution Transfer Device 2025-01-22
K222718 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Vial Adapter 2023-03-10
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2017 Baxter Corporation Englewood 2
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009631669. Last updated year: 2026. Please use registration number 3009631669 when referencing this establishment in official correspondence.
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