DIACLEAR 106887

GUDID 37332414066315

The DIACLEAR ultrafilter is intended to be used only with either HOSPAL Integra or Innova or GAMBRO Phonenix dialysis machines. It is indicated for pu

GAMBRO INDUSTRIES

Intravenous line filter
Primary Device ID37332414066315
NIH Device Record Keydf402d02-62f8-489c-93e0-af4d91712868
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIACLEAR
Version Model Number106887
Catalog Number106887
Company DUNS393020474
Company NameGAMBRO INDUSTRIES
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414066314 [Primary]
GS137332414066315 [Package]
Contains: 07332414066314
Package: CASE [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSUBSYSTEM, WATER PURIFICATION

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 Date2016-09-24

Devices Manufactured by GAMBRO INDUSTRIES

50085412917691 - PRISMAFLEX SET2022-11-30 Disposable extracorporeal circuit
50085412954078 - PRISMAFLEX SET2022-11-30 Disposable extracorporeal circuit
50085412954108 - PRISMAFLEX SET2022-11-30 Disposable extracorporeal circuit
37332414064540 - PRISMAFLEX SET2020-02-13 The Prismaflex M60 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries
37332414064557 - PRISMAFLEX SET2020-02-13 The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countrie
37332414069316 - PRISMAFLEX SET2020-02-13 The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where Pr
37332414090006 - PRISMAFLEX SET2020-02-13 The Prismaflex M150 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countrie
07332414111038 - PRISMAFLEX TPE 2000 SET2020-02-13 The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in count

Trademark Results [DIACLEAR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIACLEAR
DIACLEAR
78174653 2841739 Live/Registered
Gambro Lundia AB
2002-10-15
DIACLEAR
DIACLEAR
74357241 1797504 Dead/Cancelled
Plunk, Larry D.
1993-02-05
DIACLEAR
DIACLEAR
74164998 not registered Dead/Abandoned
Plunk, Larry D.
1991-05-09
DIACLEAR
DIACLEAR
72043358 0666295 Dead/Expired
WALLACE, DAVIS COMPANY, THE
1958-01-02

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