MedSource Labs, LLC

FDA Device Registration & Listing · Chanhassen, MN, US · Registration 3003674698

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
3003674698
FEI Number
3003674698
Entity Name
MedSource Labs, LLC
City/State/Country
Chanhassen, MN, US
Establishment Address
8600 Shelby Court, Suite 100, Chanhassen, MN 55317, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
MEDSOURCE LABS, LLC (Owner Number: 9050135)
Owner / Operator Contact Address
8600 Shelby Court, Suite 100, --, Chanhassen, MN 55317, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stretcher for Ambulance Car stretcher CPR Board Pediatric Immobilization Board Scoop Stretcher Folding Stretcher Spineboard Stair Chair Stair Stretcher combo basket stretcher pedi board Fixation Device for Stair Chair Folding backboard DialySafe HemoDialysis Connector Cannula Flared Cannula Nonflared Soft Cannula Nasal Cannula Nasal Cannula Flared Connecting Tubing Nasal Cannula Nonflared Nasal Cannula Tubing Oxygen Delivery Kit Soft Cannula Univ. Conn. Nasal Cannula univ. Conn. Adaptor Universal Soft Cannula tubing Nasal Cannula curved prong Oxygen nasal Cannula Pocket CPR Mask Yankaeur Tip only, Vented Curaplex Yankauer without Vent Yankaeur Tube only Yankaeur Tube only, Vented Yankaeur Tip & Tube, Non-Vented Yankaeur Tip only, Non-Vented Yankaeur Tip & Tube, Vented MedSource standard disposable blades and handles Medsource fiber optic blades and handles MedSource standard reusable blades and handles Lancet MedSource Endotracheal tube uncuffed MedSource Endotracheal tubes cuffed with stylet MedSource Endotracheal tubes cuffed MedSource Endotracheal tube uncuffed with stylet TrueSafe Safety IV Catheter TrueSafe Comfort Safety IV Catheter TrueSafe Blood Control IV Safety Catheter TrueSafe Comfort Blood Control IV Safety Catheter Self-Adherent Wrap Oxygen Regulator Aluminum Ohmeda Adapter Flow Meter Christmas Tree Adaptor Oxygen Regulator Brass Chemetron Adapter MedSource Sharps Dart Dental Kit Nebulizer hand held Nebulizer with mask Nebulizer without mask RightSpot pH Indicator Sharps Containers Suction Catheter Triangular Bandage, nonwoven Vacuumed Sealed Triangular Bandage Adaptor Disposable Nitrile Gloves, Powder Free Multi-Strap Strapping System 11 Point Strap Plastic Buckle One Piece Safety strap for Quick Connect Carrier Multi Strap Saver Scoop Stretcher Disposable Strap Baird Strap Metal Buckle w/swivel clips Cold Pack Medical ear loop mask Carbon dioxide sampling cannula Biopsy Punch IV Start Kits Match-complete set Personal Access Bag Multi-Purpose Collection Bag, with Hook MedSource Emesis Bag Dispenser Emesis Bag, Blue Non-Contact Infrared Thermometer Pulse Oximeter, w/ SPO2, PR & Plethbar Hand Held pulse ox SPO2 Sensor for hand-held MedSource burn sheet Glucometer Glucometer test strips Glucometer lancets Glucometer test solution Disposable Pen Light w/Pupil Gauge Disposable Penlight Head Immobilizer Extrication Device Straps Traction Leg Splint Extremity Kit MedSource TrueSafe Blood control IV safety Catheter MedSource ClearSafe Blood Control IV safety Catheter Infrared Non-Contact Thermometer Standard IV Catheter VeroTrue IV Catheter Digital Ear Thermometer IV Guard Site-Loc Flex-all Splint Poly tissue pillowcase Poly tissue flat sheet Shears Paulsen Airway IV Pole 4 hook, metal base IV Pole - 2 hook, plastic base Nursoscope Sprague Stethoscope Dual-Head Stethoscope PVP prep pads Alcohol Prep Pads CPR Face Shield w/Pouch & Gloves CPR Face Shield w/pouch Face Shield, Disposable Stylet MedSource ET Stylet Rebreather Under-Lip, U. Conn Rebreather Elongated, U. Conn

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPO Stretcher, Wheeled General Hospital Class 2 880.6910 2023-01-13
FPP Stretcher, Hand-Carried General Hospital Class 1 880.6900 2011-10-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-07-29
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2011-08-13
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2009-01-14
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2011-08-13
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2012-05-15
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-06-13
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2024-06-13
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2009-01-14
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2017-04-06
FQM Bandage, Elastic General Hospital Class 1 880.5075 2011-10-18
CAN Regulator, Pressure, Gas Cylinder Anesthesiology Class 1 868.2700 2011-10-18
MMK Container, Sharps General Hospital Class 2 880.5570 2015-05-08
OFX General Purpose Dental Tray Dental Class 1 872.6640 2026-06-10
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2011-10-18
JLL Tubeless Analysis, Gastric Acidity Clinical Chemistry Class 1 862.1320 2022-11-17
MMK Container, Sharps General Hospital Class 2 880.5570 2020-10-27
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2023-01-10
ILI Sling, Arm Physical Medicine Class 1 890.3640 2011-10-18
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2024-06-12
PXC Personal Protection Kit General Hospital Class 1 880.6250 2021-07-20
NZD Stretcher, Patient Restraint General Hospital Class 1 880.6900 2011-10-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-05-28
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2011-10-18
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2023-09-29
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2021-06-18
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2021-06-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-06-22
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2016-06-06
LRS I.V. Start Kit General Hospital Class 2 880.5200 2024-05-24
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2025-03-06
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2025-03-06
FNY Basin, Emesis General Hospital Class 1 880.6730 2011-10-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-05-27
DQA Oximeter Cardiovascular Class 2 870.2700 2020-06-11
FPY Sheet, Burn General Hospital Class 1 880.5180 2011-10-18
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2015-04-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-09-26
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2016-09-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-09-26
KYT Light, Examination, Medical, Battery Powered General Hospital Class 1 880.6350 2011-10-18
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2011-09-16
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-09-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-26
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2020-08-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-07-26
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2011-10-18
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2011-10-18
FMW Cover, Mattress (Medical Purposes) General Hospital Class 1 880.6190 2011-10-18
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 2011-10-18
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2011-10-18
FOX Stand, Infusion General Hospital Class 1 880.6990 2011-10-18
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2011-10-18
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2024-06-12
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2023-09-29
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-06-09
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2021-01-28
BYW Device, Rebreathing Anesthesiology Class 1 868.5675 2021-05-26

Official Correspondent

Emilie Andrews

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDSOURCE LABS, 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
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
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-05 Stryker Medical 2
Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
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 3003674698. Last updated year: 2026. Please use registration number 3003674698 when referencing this establishment in official correspondence.
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