Tablo Hemodialysis Concentrate B-100

GUDID 00850001011037

Liquid bicarbonate concentrate, 45X, 1 U.S. gallon

OUTSET MEDICAL, INC.

Haemodialysis concentrate
Primary Device ID00850001011037
NIH Device Record Key2d9c6fb7-4508-4a51-a40f-6bb098781c1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTablo Hemodialysis Concentrate
Version Model NumberPN-0000831
Catalog NumberB-100
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 Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001011037 [Primary]
GS110850001011034 [Package]
Package: Corrugated carton [4 Units]
In Commercial Distribution

FDA Product Code

KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-13
Device Publish Date2016-01-29

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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