EndoFLIP

GUDID 10884521809321

PRE USE CHECK KIT LK-200 FLIP

Covidien LP

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system

• Primary Device ID: 10884521809321
• NIH Device Record Key: ca666c2a-0588-464b-bc11-f4cd94b11c80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoFLIP
• Version Model Number: LK-200
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521809321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183072

FDA Product Code

• FFX: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [EndoFLIP]

• 20884521809427: ENDO CATHETER EF-325N 8CM NASAL TIP
• 20884521809410: ENDO CATHETER EF-322N 16CM NASAL TIP
• 10884521809376: LK-103 ENDOFLIP LOCALIZATION KIT US
• 10884521809321: PRE USE CHECK KIT LK-200 FLIP
• 10884521809314: TOPOGRAPHY SYSTEM DD-961
• 10884521809307: ENDOFLIP 1 SYSTEM EF-100
• 10884521808096: Endoflip system 1.0 refurbished
• 10884521826823: 300 Cart
• 10884521827691: Pre-Use Tube
• 10884521826830: 300 Reader
• 10884521826816: 300 Display System With Reader
• 10884521826809: 300 Pump System With Pre-Use Tube
• 10884521833869: Refurbished 300 Pump System With Pre-Use Tube