Tablo Cartridge CART-200

GUDID 10850001011072

Tablo Cartridge with Needleless Infusion Ports

OUTSET MEDICAL, INC.

Haemodialysis blood tubing set, single-use
Primary Device ID10850001011072
NIH Device Record Key16e3788a-59da-4686-b9cb-14c4f1ed7f2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTablo Cartridge
Version Model NumberPN-0002305
Catalog NumberCART-200
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
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 *Store in a clean, dry, indoor location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry, indoor location

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001011075 [Primary]
GS110850001011072 [Package]
Contains: 00850001011075
Package: Carton [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 Number5
Public Version Date2019-06-07
Device Publish Date2017-04-11

On-Brand Devices [Tablo Cartridge]

10850001011072Tablo Cartridge with Needleless Infusion Ports
00850001011013DWG-3008

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