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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2023-01-13 |
| Stretcher, Hand-Carried | FPP | Class 1 | General Hospital | No | 2011-10-18 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2025-07-29 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2011-08-13 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2009-01-14 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2011-08-13 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2012-05-15 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-06-13 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2024-06-13 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2009-01-14 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2017-04-06 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2011-10-18 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2011-10-18 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2015-05-08 |
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2026-06-10 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2011-10-18 |
| Tubeless Analysis, Gastric Acidity | JLL | Class 1 | Clinical Chemistry | No | 2022-11-17 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-01-10 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2011-10-18 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2024-06-12 |
| Personal Protection Kit | PXC | Class 1 | General Hospital | No | 2021-07-20 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2011-10-18 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-05-28 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2011-10-18 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-09-29 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2021-06-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-06-02 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2016-06-06 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2024-05-24 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2025-03-06 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2025-03-06 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2011-10-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-06-11 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2011-10-18 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2016-09-26 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2016-09-26 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-09-26 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2011-10-18 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2011-09-16 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2011-10-18 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2011-10-18 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2011-10-18 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2011-10-18 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2011-10-18 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2011-10-18 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2024-06-12 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2023-09-29 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-06-09 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2021-01-28 |
| Device, Rebreathing | BYW | Class 1 | Anesthesiology | No | 2021-05-26 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2024-06-12 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-12-23 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2011-10-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2011-10-18 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2022-05-04 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2011-10-18 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2011-08-13 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2011-10-18 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2011-07-07 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2018-08-16 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2011-08-13 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2011-10-18 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2022-12-12 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2011-04-06 |
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