Renaflo II Hemofilter

GUDID 30677964059149

MEDIVATORS INC.

Haemofilter

• Primary Device ID: 30677964059149
• NIH Device Record Key: e76a7b25-9083-493c-9755-b5b0b0297bac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renaflo II Hemofilter
• Version Model Number: HF 1200
• 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	00677964059148 [Primary]
GS1	30677964059149 [Package]; Contains: 00677964059148; Package: Carton [12 Units]; Discontinued: 2019-02-15; Not 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: 5
• Public Version Date: 2019-02-15
• Device Publish Date: 2016-09-16

On-Brand Devices [Renaflo II Hemofilter]

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