H2H Rinse Line

GUDID 10896241002364

H2H Rinse Line and packaging information

NEPHROS, INC.

Haemodialysis water purification system washer/disinfector

• Primary Device ID: 10896241002364
• NIH Device Record Key: aaf06adc-752e-4590-bfd9-0cbd3b1d229a
• Commercial Distribution Discontinuation: 2021-09-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: H2H Rinse Line
• Version Model Number: 70-5827
• Company DUNS: 120664557
• Company Name: NEPHROS, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896241002367 [Primary]
GS1	10896241002364 [Package]; Contains: 00896241002367; Package: Carton [80 Units]; Discontinued: 2021-09-16; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112314

FDA Product Code

• FIP: Subsystem, Water Purification

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-17
• Device Publish Date: 2017-12-21

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