Genius 8884810055

GUDID 20884521000367

Tympanic Probe Covers

Covidien LP

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

• 10884521850033 - Emprint HP: 2025-03-12 Ablation Generator with Thermosphere Technology 150W;Caution: For manufacturing, processing, or repacking.
• 20884521837468 - DAR: 2025-02-18 Adult-Pediatric Electrostatic Filter HME Small, Tethered Cap
• 20884521837482 - DAR: 2025-02-18 Adult-Pediatric Electrostatic Filter HME with Connector Small, Tethered Cap
• 20884521827636 - EEA: 2025-02-17 CIR STPLR TRIEEAXL21MT wTRISTP nORVL
• 20884521827643 - EEA: 2025-02-17 CIR STPLR TRIEEAXL21XT BLK wTRISTP nORVL
• 20884521827650 - EEA: 2025-02-17 CIR STPLR TRIEEAXL25MT wTRISTP nORVL
• 20884521827667 - EEA: 2025-02-17 CIR STPLR TRIEEAXL25XT BLK wTRISTP nORVL
• 20884521828992 - DAR: 2025-02-17 Adult Electrostatic Filter HME Large