BluPRO® TL-260T

GUDID 14931921863357

SpO2 Probe, multi-site Y probe, disposable

NIHON KOHDEN CORPORATION

Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use
Primary Device ID14931921863357
NIH Device Record Key1214fc57-8213-4840-b517-0642159b8a6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluPRO®
Version Model NumberTL-260T
Catalog NumberTL-260T
Company DUNS690568050
Company NameNIHON KOHDEN CORPORATION
Device Count5
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104931921863350 [Unit of Use]
GS114931921863357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-19

On-Brand Devices [BluPRO®]

04931921877494Finger probe Adult, child (20 kg or more) Finger or toe
04931921877432Finger probe Adult, child (20 kg or more) Finger or toe
04931921871188Multi-site probe Adults, child (3 kg or more)
04931921852712Finger probe Adult, child (20kg or more) Finger
14931921878597SpO2 probe Child / Infant (from 3 to 20 kg) Finger or toe, disposable
14931921878573SpO2 probe Adults (40 kg or more) Finger or toe, disposable
14931921878559SpO2 probe Child (from 10 to 50 kg) Finger or toe, disposable
14931921878535SpO2 probe Adults (30 kg or more) Finger or toe, disposable
14931921874308SpO2 Probe Infant (from 3 to 20 kg) finger or toe, disposable
14931921874285SpO2 probe Neonate (less than 3kg) instep, Adults (40 kg or more) Finger or toe, disposable
14931921874261SpO2 probe Child (from 10 to 50 kg) Finger or toe, disposable
14931921874247SpO2 probe Adults (30 kg or more) Finger or toe, disposable
14931921863357SpO2 Probe, multi-site Y probe, disposable
04931921005828SpO2 probe Adults (30 kg or more) Finger or toe, disposable
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