4-001837-00

GUDID 10884521127081

Mouthpiece

Covidien LP

CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use

• Primary Device ID: 10884521127081
• NIH Device Record Key: a5324a18-ca4e-46b2-a24a-e821da1b2879
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4-001837-00
• Catalog Number: 4-001837-00
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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
• 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 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521127081 [Package]; Contains: 20884521127088; Package: CASE [9999 Units]; In Commercial Distribution
GS1	20884521127088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890193

FDA Product Code

• BYG: MASK, OXYGEN

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: 2018-09-19
• Device Publish Date: 2018-08-19

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• 30884522005542 - Shiley: 2024-06-07 Oral/Nasal Tracheal Tube Cuffless
• 20884521047690 - Roticulator: 2024-05-31 Articulating Stapler
• 20884521047706 - Roticulator: 2024-05-31 Articulating Stapler
• 20884521047713 - Roticulator: 2024-05-31 Articulating Stapler
• 20884521047720 - Roticulator: 2024-05-31 Articulating Stapler