REVACLEAR 114745L

GUDID 37332414123056

Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis

GAMBRO RENAL PRODUCTS, INC.

Hollow-fibre haemodialysis dialyser, single-use
Primary Device ID37332414123056
NIH Device Record Keyebdae05d-c755-4ed6-bb61-0692b9c6270f
Commercial Distribution StatusIn Commercial Distribution
Brand NameREVACLEAR
Version Model Number300
Catalog Number114745L
Company DUNS929768682
Company NameGAMBRO RENAL PRODUCTS, INC.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414123055 [Primary]
GS137332414123056 [Package]
Contains: 07332414123055
Package: CASE [24 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-08

On-Brand Devices [REVACLEAR]

37332414124077Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodial
37332414123056Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failu

Trademark Results [REVACLEAR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVACLEAR
REVACLEAR
85768855 4424307 Live/Registered
GAMBRO LUNDIA AB
2012-11-01

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