CLEARUM HS

GUDID 68051736004132

CLEARUM HS 13 High Flux dialyzer

BELLCO SRL

Hollow-fibre haemodialysis dialyser, single-use
Primary Device ID68051736004132
NIH Device Record Key18ba096e-92a2-4aed-96ef-88de1a650cf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLEARUM HS
Version Model NumberIBP4370
Company DUNS338685723
Company NameBELLCO SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0
Area/Surface Area1.3 Square meter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108051736004130 [Primary]
GS168051736004132 [Package]
Contains: 08051736004130
Package: CASE [21 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-11
Device Publish Date2021-01-01

On-Brand Devices [CLEARUM HS]

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

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