Tablo(R) Cartridge CART-301

GUDID 00850001011143

The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis.

OUTSET MEDICAL, INC.

Haemodialysis blood tubing set, single-use
Primary Device ID00850001011143
NIH Device Record Keyf0707176-fec2-40d5-83f8-83f26ec7c49c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTablo(R) Cartridge
Version Model NumberPN-0004221
Catalog NumberCART-301
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001011143 [Primary]
GS110850001011140 [Package]
Package: Case [6 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 Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2019-01-11

On-Brand Devices [Tablo(R) Cartridge]

00850001011143The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to pr
00850001011273Tablo Cartridge, Needleless, X, with Formula Organizer
00850001011259Tablo X Cartridge, OMM

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