Sentri™ Intersurgical EcoLite™ concentration oxygen mask Kit

GUDID 00816472021876

Sentri™ Intersurgical EcoLite™ concentration oxygen mask Kit with U-Connector, Adult

Intersurgical Incorporated

Rebreathing oxygen face mask
Primary Device ID00816472021876
NIH Device Record Key23544781-b74d-4300-b901-5fb200f5e782
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentri™ Intersurgical EcoLite™ concentration oxygen mask Kit
Version Model Number11436100
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816472021869 [Primary]
GS100816472021876 [Package]
Contains: 00816472021869
Package: [30 Units]
In Commercial Distribution

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

Devices Manufactured by Intersurgical Incorporated

00816472020435 - Filta-Therm™ HMEF with luer port, retainable cap and Flextube™2025-02-11 Filta-Therm™ HMEF with luer port, retainable cap and Flextube™
00816472020558 - Breathing Circuit2025-02-11 Breathing Circuit, 22mm, nonconductive, single use, MRI Safe
00816472020695 - Convenience Pack with 12" Flex Tube2025-02-11 Convenience Pack with 12" Flex Tube
00816472021852 - Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line2025-02-11 Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line with universal connector tube, 1.8m
00816472022217 - Smoothbore breathing system without exhalation port, 22mm, 1.6m2025-02-11 Smoothbore breathing system without exhalation port, 22mm, 1.6m
00816472022538 - Multipac® Anesthesia Breathing System2025-02-11 Multipac® Anesthesia Breathing System
00816472023610 - Smoothbore circuit, 22mm2025-02-11 Smoothbore circuit, 22mm
00816472023696 - Multipac Anesthesia Breathing Circuit2025-02-11 Multipac Anesthesia Breathing Circuit

Trademark Results [Sentri]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SENTRI
SENTRI
98545198 not registered Live/Pending
Rieke LLC
2024-05-10
SENTRI
SENTRI
90599280 not registered Live/Pending
Sentri Institute Inc.
2021-03-24
SENTRI
SENTRI
88955091 not registered Live/Pending
Mar Cor Purification, Inc.
2020-06-09
SENTRI
SENTRI
88131220 not registered Live/Pending
PYXUS INTERNATIONAL, INC.
2018-09-25
SENTRI
SENTRI
88125681 not registered Live/Pending
PYXUS INTERNATIONAL, INC.
2018-09-20
SENTRI
SENTRI
87167689 not registered Live/Pending
Mar Cor Purification, Inc.
2016-09-12
SENTRI
SENTRI
87028243 not registered Dead/Abandoned
Oculia LLC
2016-05-06
SENTRI
SENTRI
86585564 not registered Dead/Abandoned
Sentri, Inc.
2015-04-02
SENTRI
SENTRI
86424314 5134097 Live/Registered
Sentri, Inc.
2014-10-15
SENTRI
SENTRI
78696020 not registered Dead/Abandoned
Berger, Steven
2005-08-19
SENTRI
SENTRI
77140067 not registered Dead/Abandoned
Neil Peter Gillan
2007-03-26
SENTRI
SENTRI
75292021 not registered Dead/Abandoned
B-Tree Verification Systems, Inc.
1997-05-14

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.