Criterion OxiCheck 8-100661-00

GUDID 00884838083189

RESPIRONICS NOVAMETRIX, LLC

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• Primary Device ID: 00884838083189
• NIH Device Record Key: 1baeb5e5-007d-4937-b1de-793f09da3c78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Criterion OxiCheck
• Version Model Number: 00
• Catalog Number: 8-100661-00
• Company DUNS: 093608594
• Company Name: RESPIRONICS NOVAMETRIX, LLC
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• 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(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM
• Phone: +1(203)697-6450
• Email: OEM.RESPIRONICS@PHILIPS.COM

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838083189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023565

FDA Product Code

• CCL: ANALYZER, GAS, OXYGEN, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-06

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• 00884838104785 - Respironics: 2024-02-23 Pediatric/Adult Airway Adapter
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• 00884838104891 - Respironics: 2024-02-23 Cannula Nasal CO2/O2 Infant