Flow-Safe Anti-Asphyxia Valve Elbow

GUDID 10641043571217

For use with Flow-Safe, Flow-Safe II, Flow-Safe IIEZ

MERCURY ENTERPRISES, INC.

Ventilator breathing circuit, single-use
Primary Device ID10641043571217
NIH Device Record Key7444bf73-2ff1-4bdd-af32-1a4c16748738
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlow-Safe Anti-Asphyxia Valve Elbow
Version Model Number10-57121
Company DUNS032705659
Company NameMERCURY ENTERPRISES, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(727) 573-0088
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS110641043571217 [Primary]
GS130641043571211 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-27
Device Publish Date2016-09-24

Devices Manufactured by MERCURY ENTERPRISES, INC.

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30641043571082 - Deluxe Full Face Mask2019-12-06
30641043571075 - Deluxe Full Face Mask2019-12-06
30641043571068 - Deluxe Full Face Mask2019-12-06
30641043570177 - Flow-Safe Disposable CPAP System2019-12-06

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