CARESCAPE CO2 - LOFLO 1124218

GUDID 00884838074736

used with LoFlo Sidestream CO2 Module Ref: 1069879

RESPIRONICS NOVAMETRIX, LLC

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 00884838074736
• NIH Device Record Key: 188a8126-62e7-4de0-aa08-225677a21364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESCAPE CO2 - LOFLO
• Version Model Number: 00
• Catalog Number: 1124218
• Company DUNS: 093608594
• Company Name: RESPIRONICS NOVAMETRIX, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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(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 -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838074736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053174

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-14

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