NxStage PureFlow Solution

GUDID 10842289103105

NXSTAGE MEDICAL, INC.

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• Primary Device ID: 10842289103105
• NIH Device Record Key: 0f7c9771-c191-4676-822d-df3b7989eb3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NxStage PureFlow Solution
• Version Model Number: RFP-221-A
• 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
• 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
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842289103108 [Primary]
GS1	10842289103105 [Package]; Contains: 00842289103108; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-04
• Device Publish Date: 2024-03-27

On-Brand Devices [NxStage PureFlow Solution]

• 10842289103136: RFP-224-A
• 10842289103129: RFP-223-A
• 10842289103112: RFP-222-A
• 10842289103105: RFP-221-A
• 10842289103099: RFP-220-A
• 10842289103082: RFP-205-A
• 10842289103075: RFP-211-A
• 10842289103068: RFP-209-A
• 10842289103051: RFP-204-A
• 10842289103044: RFP-207-A