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

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30884522020279 - DAR2025-03-18 Catheter Mount
10884522034753 - DAR2025-03-18 Catheter Mount Extendable
10884522034791 - DAR2025-03-18 Catheter Mount Extendable
20884521066172 - DAR2025-03-17 Catheter Mount Extendable
10884521528086 - DAR2025-03-17 Catheter Mount
20884522020081 - DAR2025-03-17 Catheter Mount
30884522020118 - DAR2025-03-17 Catheter Mount

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