VersiHD with GuideMe software

GUDID M535NX100010F0

NXSTAGE MEDICAL, INC.

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• Primary Device ID: M535NX100010F0
• NIH Device Record Key: e5b21ff6-d3d3-422b-9bd8-53ea813810b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersiHD with GuideMe software
• Version Model Number: NX1000-10-F
• 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
• 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 -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M535NX100010F0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230632

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

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: 2023-08-29
• Device Publish Date: 2023-08-21

On-Brand Devices [VersiHD with GuideMe software]

• M535NX100016F0: NX1000-16-F
• M535NX100010F0: NX1000-10-F
• M535NX100010E0: NX1000-10-E