Puritan Bennett S-232102-00B

GUDID 10884521134515

Narrow Shell Assembly,For Soft Headgear CPAP Interface Circuit

Covidien LP

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 10884521134515
• NIH Device Record Key: 844d46f8-02df-4245-81b0-1515ad35cce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puritan Bennett
• Version Model Number: S-232102-00B
• Catalog Number: S-232102-00B
• 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: 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 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521134515 [Package]; Contains: 20884521134512; Package: CASE [20 Units]; In Commercial Distribution
GS1	20884521134512 [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: 2018-10-01
• Device Publish Date: 2018-08-29

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• 10884521134812: CPAP Interface with Nasal Cushion Assembly,Standard
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• 10884521134720: CPAP Interface without Nasal Pillows Assembly
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• 10884521134706: Soft Headgear CPAP Interface Circuit Kit,Large, Narrow Shell
• 10884521134683: Soft Headgear CPAP Interface Circuit Kit,Large, Standard Shell
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• 10884521134447: Calibration Shell,For Soft Headgear CPAP Interface Circuit
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