BioPure HX2

GUDID 00817492021839

Biolab Equipment Ltd

Reverse-osmosis water purification system

• Primary Device ID: 00817492021839
• NIH Device Record Key: 84b90b48-8cca-4033-81c5-252a1f0f499b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPure HX2
• Version Model Number: HX2P-05811XX
• 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

• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch
• Width: 166 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817492021839 [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: 2017-06-12

On-Brand Devices [BioPure HX2]

• 00817492021853: HX2P-11811XX
• 00817492021846: HX2P-11611XX
• 00817492021839: HX2P-05811XX
• 00817492021822: HX2P-05611XX
• 00817492021723: HX2P-1181XXX
• 00817492021716: HX2P-1161XXX
• 00817492021709: HX2P-HX2P-0581XXX
• 00817492021693: HX2P-0561XXX