Tablo(R) Straws PN-0004467, PN-0005451

GUDID 10850001011164

Straws, for concentrate bottles

OUTSET MEDICAL, INC.

Haemodialysis dialysate tubing, single-use
Primary Device ID10850001011164
NIH Device Record Key9ab63416-624c-4d32-a5be-aa7a79552794
Commercial Distribution StatusIn Commercial Distribution
Brand NameTablo(R) Straws
Version Model NumberPN-0004378
Catalog NumberPN-0004467, PN-0005451
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001011167 [Primary]
GS110850001011164 [Package]
Contains: 00850001011167
Package: cardboard box [12 Units]
In Commercial Distribution
GS120850001011161 [Package]
Contains: 00850001011167
Package: cardboard box [48 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(R) Straws]

10850001011164Straws, for concentrate bottles
10850001011133Straws, for concentrate bottles

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