Pedi-POM EZ-Lite MSA

GUDID 20851438008151

Pediatric Procedural Oxygen Mask - Medium Concentration & CO2 Monitoring (Microstream™ Compatible)

STRYKER CORPORATION

Capnography oxygen mask

• Primary Device ID: 20851438008151
• NIH Device Record Key: bc910807-afb5-49d1-99eb-701872d0c6e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedi-POM EZ-Lite MSA
• Version Model Number: 1003-MSA-PED
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• 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: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: (855) 766-0202
• Email: info@pommedical.net
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +0018002533210
• Email: Inst.Stryker.cs@Stryker.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851438008154 [Primary]
GS1	20851438008151 [Package]; Contains: 10851438008154; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172365

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-06-21
• Device Publish Date: 2018-07-11

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