Flow-Safe II Low FiO2 Elbow

GUDID 10641043571286

MERCURY ENTERPRISES, INC.

Ventilator breathing circuit, single-use
Primary Device ID10641043571286
NIH Device Record Key693763d6-33cc-4157-9487-2e1d5335959a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlow-Safe II Low FiO2 Elbow
Version Model Number10-57128
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 Datefalse
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
GS110641043571286 [Primary]
GS130641043571280 [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 Number4
Public Version Date2019-11-27
Device Publish Date2017-10-16

Devices Manufactured by MERCURY ENTERPRISES, INC.

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