Nx2me Connected Health Nx2me Clinician Portal

GUDID M535NX1225NX1380

NXSTAGE MEDICAL, INC.

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• Primary Device ID: M535NX1225NX1380
• NIH Device Record Key: 7b7cfe9d-9c77-4865-be5e-c5d81defe357
• Commercial Distribution Discontinuation: 2021-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Nx2me Connected Health Nx2me Clinician Portal
• Version Model Number: NX1380
• 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: false
• Manufacturing Date: false
• 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
• Phone: 1-866-697-8243
• Email: info@nxstage.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M535NX1225NX1380 [Primary]

FDA Product Code

• FKP: System, Dialysate Delivery, Single Patient

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-06-08
• Device Publish Date: 2015-09-01

Devices Manufactured by NXSTAGE MEDICAL, INC.

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• 10842289103099 - NxStage PureFlow Solution: 2024-04-04
• 10842289103105 - NxStage PureFlow Solution: 2024-04-04
• 10842289103112 - NxStage PureFlow Solution: 2024-04-04