Renaflo II Hemofilter

GUDID 30677964000073

MEDIVATORS INC.

Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter Haemofilter

• Primary Device ID: 30677964000073
• NIH Device Record Key: 034207da-a159-4329-918b-2494282c160d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renaflo II Hemofilter
• Version Model Number: HF 700
• Company DUNS: 068199363
• Company Name: MEDIVATORS 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964000072 [Primary]
GS1	30677964000073 [Package]; Contains: 00677964000072; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923312

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [Renaflo II Hemofilter]

• 30677964059149: HF 1200
• 30677964000073: HF 700
• 30677964000066: HF 400
• 30677964000080: HF 1200