CLEARUM HS

GUDID 68051736004170

CLEARUM HS 22 High Flux dialyzer

BELLCO SRL

Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 68051736004170
• NIH Device Record Key: 45a5c963-e06e-42a2-ab5b-a85482f90639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARUM HS
• Version Model Number: IBP4374
• Company DUNS: 338685723
• Company Name: BELLCO SRL
• 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: 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0
• Area/Surface Area: 2.2 Square meter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051736004178 [Primary]
GS1	68051736004170 [Package]; Contains: 08051736004178; Package: CASE [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193542

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-11
• Device Publish Date: 2021-01-01

On-Brand Devices [CLEARUM HS]

• 68051736004170: CLEARUM HS 22 High Flux dialyzer
• 68051736004163: CLEARUM HS 20 High Flux dialyzer
• 68051736004156: CLEARUM HS 17 High Flux dialyzer
• 68051736004149: CLEARUM HS 15 High Flux dialyzer
• 68051736004132: CLEARUM HS 13 High Flux dialyzer
• 68051736007041: CLEARUM HS 17 High Flux dialyzer