NX2ME APP

GUDID 00842289101883

NXSTAGE MEDICAL, INC.

Medical equipment clinical data interfacing software

• Primary Device ID: 00842289101883
• NIH Device Record Key: 4847dfcf-d8d8-4f36-a764-ba655a00af59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NX2ME APP
• Version Model Number: NX3094
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842289101883 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-15

Devices Manufactured by NXSTAGE MEDICAL, INC.

• 00842289103894 - VersiHD with GuideMe Software: 2025-10-01
• 00842289104044 - VersiHD with GuideMe Software: 2025-10-01
• 00842289104051 - VersiHD with GuideMe Software: 2025-10-01
• M535RFP205WW5 - NxStage PureFlow Solution: 2025-07-23
• 00842289103870 - NXSTAGE CARTRIDGE EXPRESS: 2024-08-01
• 00842289103887 - NXSTAGE CARTRIDGE EXPRESS: 2024-08-01
• 10842289103044 - NxStage PureFlow Solution: 2024-04-04
• 10842289103051 - NxStage PureFlow Solution: 2024-04-04