NxStage PureFlow-B Solution

GUDID 10842289101255

NXSTAGE MEDICAL, INC.

Haemodialysis dialysate solution

• Primary Device ID: 10842289101255
• NIH Device Record Key: f43d247a-8b0f-49fe-a6a5-5a84ab30caa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NxStage PureFlow-B Solution
• Version Model Number: RFP-400-BB
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-697-8243
• Email: info@nxstage.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842289101258 [Primary]
GS1	10842289101255 [Package]; Contains: 00842289101258; Package: Shipping Box [2 Units]; In Commercial Distribution

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-11

On-Brand Devices [NxStage PureFlow-B Solution]

• 10842289101262: RFP-401-BB
• 10842289101255: RFP-400-BB