FDA Registration Active 🇺🇸 United States

MedSource Labs, LLC

Reg #: 3003674698 · FEI: 3003674698 · Expires 2026
Products
64
Proprietary Names
206
Establishment Types
4
Classifications
64

Registration Details

Registration Name
MedSource Labs, LLC
Registration Number
3003674698
FEI Number
3003674698
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
8600 Shelby Court, Suite 100
City
Chanhassen
State
MN
ZIP
55317
Country
US

Regulatory Submissions

510(k) Number
K222889

Owner / Operator

Firm Name
MEDSOURCE LABS, LLC
Operator Number
9050135
Address
8600 Shelby Court, Suite 100, --
City
Chanhassen
State
MN
Postal Code
55317
Country
US
Correspondent
Emilie Andrews

Products

Device Name Product Code
Stretcher, Wheeled FPO
Stretcher, Hand-Carried FPP
Set, Administration, Intravascular FPA
Cannula, Nasal, Oxygen CAT
Valve, Non-Rebreathing CBP
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Laryngoscope, Rigid CCW
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
Multiple Use Blood Lancet For Single Patient Use Only QRL
Tube, Tracheal (W/Wo Connector) BTR
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Bandage, Elastic FQM
Regulator, Pressure, Gas Cylinder CAN
Container, Sharps MMK
General Purpose Dental Tray OFX
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
Tubeless Analysis, Gastric Acidity JLL
Catheter And Tip, Suction JOL
Sling, Arm ILI
Connector, Airway (Extension) BZA
Personal Protection Kit PXC
Stretcher, Patient Restraint NZD
Continuous Measurement Thermometer FLL
Pack, Hot Or Cold, Disposable IMD
Mask, Surgical FXX
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Instrument, Manual, Surgical, General Use MDM
Set, I.V. Fluid Transfer LHI
I.V. Start Kit LRS
Stethoscope, Manual LDE
Blood Pressure Cuff DXQ
Basin, Emesis FNY
Oximeter DQA
Sheet, Burn FPY
System, Test, Blood Glucose, Over The Counter NBW
Glucose Oxidase, Glucose CGA
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Light, Examination, Medical, Battery Powered KYT
Support, Patient Position CCX
Dressing, Wound, Hydrophilic NAC
Splint, Hand, And Components ILH
Cover, Mattress (Medical Purposes) FMW
Scissors, Medical, Disposable JOK
Airway, Oropharyngeal, Anesthesiology CAE
Stand, Infusion FOX
Pad, Alcohol, Device Disinfectant LKB
Mouthpiece, Breathing BYP
Accessory, Surgical Apparel LYU
Stylet, Tracheal Tube BSR
Device, Rebreathing BYW
Flowmeter, Tube, Thorpe, Back-Pressure Compensated CAX
Electrode, Electrocardiograph DRX
Device, Transfer, Patient, Manual FMR
Tape And Bandage, Adhesive KGX
Needle, Aspiration And Injection, Disposable GAA
Airway, Nasopharyngeal BTQ
Mask, Oxygen, Non-Rebreathing KGB
Catheters, Suction, Tracheobronchial BSY
Bedding, Disposable, Medical KME
Non-Surgical Gown OEA
Mask, Oxygen BYG
Gauze / Sponge,Nonresorbable For External Use NAB
Hook, Tracheal KCH
Tourniquet, Nonpneumatic GAX

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 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 Electrodes MedSource Patient Mover Plus Ready fit Patient mover rescue chair MedSource Patient Mover Cloth Tape-Porous Clear/ Transparent Tape Cloth/Silk Tape Paper Tape Decompression Needle MedSource 72", 15 Drop, Y-Site, Needle PRN MedSource Male Luer Lock, 21" MedSource 72", 60 Drop, Y-Site, Needle PRN MedSource 83", 15 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource Flow Regulator, 19", Split Septum Y-Site, Side Clamp MedSource 83", 10 Drop, Split Septum Y-Site, Needle PRN MedSource Needleless PRN, 8", Pinch Clamp, Rotary Male Luer Lock MedSource Needleless PRN 6", Pinch Clamp, Rotary Male Luer Lock MedSource 83", 15 Drop, Split Septum Y-Site, Needle PRN MedSource 72", 10 Drop, Y-Site, Needle PRN MedSource 83", 10 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource 88", 60 Drop, Split Septum Y-Site, Needleless PRN MedSource 83", 60 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource 83", 60 Drop, Split Septum Y-Site, Needle PRN MedSource Needleless PRN, 10", Pinch Clamp, Rotary Male Luer Lock MedSource Needleless PRN, 6", Split Septum Y-Site, Side Clamp MedSource 96", 10 Drop, two (2) Split Septum Y-Sites, Flow Regulator Silicone Nasopharyngeal Mask Oxygen, Nonrebreather Mask, Oxygen Tee Aerosol Non-Rebreather, w/ Univ. Conn Non-Rebreather High Concentrate NRB Mask Non-Rebreather with vent Mask Oxygen nonrebreather Manual Section Pump refill Cannister Manual Suction Pump MedSource I.V. Administration Set MedSource Heavy Duty Cot Sheet with Square Ends MedSource 3 Piece Linen Set MedSource Barrier Sheet MedSource Cot Sheet, Sewn Ends MedSource Cot Sheet, Fitted MedSource Pro Fitted Heavy Duty Cot Sheet MedSource Specialty Cot Sheet MedSource Ready Fit, Fitted Sheet MedSource 4 Piece Linen Set MedSource Cot Sheet, Flat MedSource Heavy Duty Cot with Pouch MedSource Heavy Duty Cot Sheet MedSource Cot Sheet Isolation Gown Disposable BP Cuff Sleeve Barrier Oxygen Mask Elongated Trah Mask Kit All Diluters, U Conn Oxygen Mask U. Conn. Aerosol Mask under chin Aerosol Mask Elongated Venturi Mask Kit All Diluters Aerosol Mask Under Lip No Tubing Tracheostomy Mask No tubing Oxygen Mask Bulk Roll Gauze, Sterile ABD pads Gauze Conforming Gauze, Sterile Multi-Trauma Dressing Non Sterile Gauze MedSource Tracheostomy Hook ClearSafe Safety IV Catheter MedSource Safety IV Catheter ClearSafe Comfort Safety IV Catheter ClearSafe Comfort Blood Control IV Safety Catheter ClearSafe Blood Control IV Safety Catheter ClearSafe Comfort with Wings IV Safety Catheter Tourniquet

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device