Genius 8884810055

GUDID 20884521000367

Tympanic Probe Covers

Covidien LP

Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover Electronic thermometer probe cover

• Primary Device ID: 20884521000367
• NIH Device Record Key: 67d5d33b-4f85-486a-8d3c-0614e0555e3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genius
• Version Model Number: 8884810055
• Catalog Number: 8884810055
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 105
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521000360 [Primary]
GS1	20884521000367 [Package]; Contains: 10884521000360; Package: CASE [2100 Units]; In Commercial Distribution
GS1	30884521000364 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920713

FDA Product Code

• FLL: Thermometer, electronic, clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-04-22
• Device Publish Date: 2017-04-20

Devices Manufactured by Covidien LP

• 10884521744134 - TruClear: 2024-04-23 Calibration Insert
• 10884521744141 - TruClear: 2024-04-23 Calibration Insert
• 10884521557048 - INVOS: 2024-04-22 Docking Station
• 10884521833869 - Endoflip: 2024-04-22 Refurbished 300 Pump System With Pre-Use Tube
• 20884521140216 - ClosureFast: 2024-04-15 Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m)
• 10884521543430 - LiquiBand Exceed: 2024-04-15 2-Octyl Cyanoacrylate
• 20884521140209 - ClosureFast: 2024-04-10 Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
• 10884521539921 - VenaSeal: 2024-04-09 VenaSeal Closure System