BioPure 4400 RO

GUDID 00817492021877

Biolab Equipment Ltd

Reverse-osmosis water purification system

• Primary Device ID: 00817492021877
• NIH Device Record Key: a6d0dfe7-3b35-4c6f-b81f-8cd0e7ca0276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPure 4400 RO
• Version Model Number: 22M18B2F
• Company DUNS: 243149549
• Company Name: Biolab Equipment Ltd
• 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: 8002685035
• Email: orderdesk@mcpur.com
• Phone: 8002685035
• Email: orderdesk@mcpur.com
• Phone: 8002685035
• Email: orderdesk@mcpur.com

Device Dimensions

• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound
• Weight: 438 Pound

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817492021877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133149

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: 4
• Public Version Date: 2018-08-27
• Device Publish Date: 2017-07-12

On-Brand Devices [BioPure 4400 RO]

• 00817492021914: 42M16BB2E
• 00817492021891: 22M16BB2F
• 00817492021884: 42M18B2F
• 00817492021877: 22M18B2F
• 00817492021860: 32M16BB2E
• 00817492021808: RO/4400V/16000USGPD/TFC/230/3/60/5.5HP/Tank Feed
• 00817492021778: 32M10B2F
• 00817492021686: 125M16B2F
• 00817492021679: 125M16B2E
• 00817492021662: 122M16B2F
• 00817492021655: 122M16B2E
• 00817492021648: 105M16B2F
• 00817492021631: 105M16B2E
• 00817492021624: 102M16B2F
• 00817492021617: 102M16B2E
• 00817492021600: 95M16B2F
• 00817492021594: 95M16B2E
• 00817492021587: 92M16B2F
• 00817492021570: 92M16B2E
• 00817492021563: 85M16B2F
• 00817492021556: 85M16B2E
• 00817492021549: 82M16B2F
• 00817492021532: 82M16B2E
• 00817492021525: 65M16B2F
• 00817492021518: 65M16B2E
• 00817492021501: 62M16B2F
• 00817492021495: 62M16B2E
• 00817492021488: 55M16B2F
• 00817492021471: 55M16B2E
• 00817492021464: 52M16B2F
• 00817492021457: 52M16B2E
• 00817492021440: 45M16B2F
• 00817492021433: 45M16B2E
• 00817492021426: 42M16B2F
• 00817492021419: 42M16B2E
• 00817492021402: 35M16B2F
• 00817492021396: 35M16B2E
• 00817492021389: 32M16B2F
• 00817492021372: 32M16B2E
• 00817492021365: 25M16B2F
• 00817492021358: 25M16B2E
• 00817492021341: 22M16B2F
• 00817492021334: 22M16B2E