H2H Substitution Filter

GUDID 10896241002074

H2H Substitution Filter and packaging information

NEPHROS, INC.

Haemodialysis system dialysate pyrogen-filtration set

• Primary Device ID: 10896241002074
• NIH Device Record Key: 225b8689-3a8b-449d-9f69-ad10415b37d7
• Commercial Distribution Discontinuation: 2021-09-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: H2H Substitution Filter
• Version Model Number: 70-6828
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896241002077 [Primary]
GS1	10896241002074 [Package]; Contains: 00896241002077; Package: Carton [5 Units]; Discontinued: 2021-09-16; Not in Commercial Distribution
GS1	20896241002071 [Package]; Package: Box [20 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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-17
• Device Publish Date: 2016-09-24

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