NuFLO2 Hyperinflation System

GUDID 30641043568099

MERCURY ENTERPRISES, INC.

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use
Primary Device ID30641043568099
NIH Device Record Key6ba34b93-9c55-4ad2-b12a-9b1ab5eb31f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuFLO2 Hyperinflation System
Version Model Number10-56809
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110641043568095 [Primary]
GS110641043568095 [Primary]
GS110641043568095 [Primary]
GS130641043568099 [Package]
Contains: 10641043568095
Package: [20 Units]
In Commercial Distribution
GS130641043568099 [Package]
Contains: 10641043568095
Package: [20 Units]
In Commercial Distribution
GS130641043568099 [Package]
Contains: 10641043568095
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHKResuscitator,Manual,Non Self-Inflating
NHKResuscitator,Manual,Non Self-Inflating
NHKResuscitator,Manual,Non Self-Inflating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2015-09-24

On-Brand Devices [NuFLO2 Hyperinflation System]

3064104356847110-56847
3064104356848810-56848
3064104356846410-56846
3064104356850110-56850
3064104356849510-56849
1064104356842210-56842
3064104356841910-56841
3064104356840210-56840
3064104356839610-56839
3064104356837210-56837
3064104356836510-56836
3064104356835810-56835
3064104356834110-56834
3064104356833410-56833
3064104356832710-56832
3064104356831010-56831
3064104356830310-56830
3064104356829710-56829
3064104356823510-56823
3064104356822810-56822
3064104356821110-56821
3064104356820410-56820
3064104356819810-56819
3064104356818110-56818
3064104356817410-56817
3064104356816710-56816
3064104356815010-56815
3064104356814310-56814
3064104356813610-56813
3064104356812910-56812
3064104356811210-56811
3064104356810510-56810
3064104356809910-56809
3064104356808210-56808
3064104356807510-56807
3064104356806810-56806
3064104356805110-56805
3064104356804410-56804
3064104356803710-56803
3064104356802010-56802
3064104356801310-56801
3064104356800610-56800

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