Flow-Safe II+ BiLevel Disposable CPAP System

GUDID 10641043574065

MERCURY ENTERPRISES, INC.

CPAP/BPAP nasal mask, single-use
Primary Device ID10641043574065
NIH Device Record Keyf8401d57-8c9d-4fc2-81a4-fd24edc9684d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlow-Safe II+ BiLevel Disposable CPAP System
Version Model Number10-57406
Company DUNS032705659
Company NameMERCURY ENTERPRISES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com
Phone(727) 573-0088
Emailhospitalcustomerservice@mercurymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110641043574065 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-22
Device Publish Date2021-01-14

On-Brand Devices [Flow-Safe II+ BiLevel Disposable CPAP System]

1064104357406510-57406
3064104357405210-57405
3064104357404510-57404

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