BluPRO® TL-201T

GUDID 00841983102684

Finger probe Adult, child (20kg or more) Finger

NIHON KOHDEN AMERICA, INC.

Pulse oximeter probe, reusable
Primary Device ID00841983102684
NIH Device Record Key2e1647aa-785c-47a7-8cee-77a4704b57b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluPRO®
Version Model NumberTL-201T
Catalog NumberTL-201T
Company DUNS021063219
Company NameNIHON KOHDEN AMERICA, 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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100841983102684 [Primary]

FDA Product Code

GWQFull-montage Standard Electroencephalograph

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 Date2016-09-19

On-Brand Devices [BluPRO®]

00841983102752Finger probe Adult, child (20 kg or more) Finger or toe
00841983102691Multi-site probe Adults, child (3 kg or more)
00841983102684Finger probe Adult, child (20kg or more) Finger
04931921019696Multi-site probe Adults, child (3 kg or more)
10841983102742SpO2 probe Child / Infant (from 3 to 20 kg) Finger or toe, disposable
10841983102735SpO2 probe Adults (40 kg or more) Finger or toe, disposable
10841983102728SpO2 probe Child (from 10 to 50 kg) Finger or toe, disposable
10841983102711SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 160cm cable
10841983102704SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 80cm cable

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.