COMFORTMATE FLUID WARMER

GUDID M535FW2000

NXSTAGE MEDICAL, INC.

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer

• Primary Device ID: M535FW2000
• NIH Device Record Key: 496029c7-d537-405c-b4b5-0350083530ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMFORTMATE FLUID WARMER
• Version Model Number: FW-200
• Company DUNS: 088013219
• Company Name: NXSTAGE MEDICAL, INC.
• 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: 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: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M535FW2000 [Primary]

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

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: 2022-03-22
• Device Publish Date: 2015-09-01

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