Tablo(R) Hemodialysis System PN-0003000

GUDID 00850001011112

The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.

OUTSET MEDICAL, INC.

Haemodialysis system, institutional
Primary Device ID00850001011112
NIH Device Record Keyb6064c95-6f58-4067-a71a-60e9c35946a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTablo(R) Hemodialysis System
Version Model NumberPN-0003000
Catalog NumberPN-0003000
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 Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001011112 [Primary]

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2019-01-11

On-Brand Devices [Tablo(R) Hemodialysis System]

00850001011112The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with
00850001011204Tablo Console

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