MD460 Reverse Osmosis System

GUDID 00852456007023

MD460 Reverse Osmosis System

ISOPURE, CORP.

Reverse-osmosis water purification system

• Primary Device ID: 00852456007023
• NIH Device Record Key: ca358afe-efdd-4702-8e85-38785b5bf6cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD460 Reverse Osmosis System
• Version Model Number: MD460
• Company DUNS: 040279650
• Company Name: ISOPURE, CORP.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852456007023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993200

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-20

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• 00852456007009 - MD420 Reverse Osmosis System: 2018-07-06 MD420 Reverse Osmosis System
• 00852456007016 - MD440 Reverse Osmosis System: 2018-07-06 MD440 Reverse Osmosis System
• 00852456007023 - MD460 Reverse Osmosis System: 2018-07-06MD460 Reverse Osmosis System
• 00852456007023 - MD460 Reverse Osmosis System: 2018-07-06 MD460 Reverse Osmosis System
• 00852456007030 - MD470 Reverse Osmosis System: 2018-07-06 MD470 Reverse Osmosis System
• 00852456007047 - MD480 Reverse Osmosis System: 2018-07-06 MD480 Reverse Osmosis System
• 00852456007054 - MD490 Reverse Osmosis System: 2018-07-06 MD490 Reverse Osmosis System