4-001837-00

GUDID 10884521127081

Mouthpiece

Covidien LP

CPAP/BPAP nasal mask, single-use
Primary Device ID10884521127081
NIH Device Record Keya5324a18-ca4e-46b2-a24a-e821da1b2879
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4-001837-00
Catalog Number4-001837-00
Company DUNS058614483
Company NameCovidien LP
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521127081 [Package]
Contains: 20884521127088
Package: CASE [9999 Units]
In Commercial Distribution
GS120884521127088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYGMASK, OXYGEN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-19
Device Publish Date2018-08-19

Devices Manufactured by Covidien LP

20884521703732 - Tri-Staple 2.02024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters
20884521703756 - Tri-Staple 2.02024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters
20884521703770 - Tri-Staple 2.02024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters
20884521822891 - DAR2024-12-09 Closed Suction System, Replaceable Catheter Endotracheal Length
10884521845480 - Signia2024-12-09 SIGNIA CIRCULAR ADAPTER STND LENGTH FT
10884521845497 - Signia2024-12-09 SIGNIA CIRCULAR ADAPTER XL LENGTH FT
20884521581859 - Barrx2024-11-18 RFA Cleaning Cap Small
20884521581866 - Barrx2024-11-18 RFA Cleaning Cap Medium

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