Tablo Hemodialysis Concentrate A-125

GUDID 00850001011105

Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon

OUTSET MEDICAL, INC.

Haemodialysis concentrate
Primary Device ID00850001011105
NIH Device Record Key40d033c1-4a84-493c-bb04-572626d688dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTablo Hemodialysis Concentrate
Version Model NumberPN-0002630
Catalog NumberA-125
Company DUNS788744477
Company NameOUTSET MEDICAL, 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 Usefalse
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

Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com
Phone844.698.2256
EmailTechnicalService@outsetmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid freezing or storage in excessive heat.
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001011105 [Primary]
GS110850001011102 [Package]
Package: carboard box [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-11
Device Publish Date2020-08-03

On-Brand Devices [Tablo Hemodialysis Concentrate]

10850001011058Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon
10850001011041Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon
00850001011037Liquid bicarbonate concentrate, 45X, 1 U.S. gallon
00850001011105Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon

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