Hyperinflation System

GUDID 10641043558676

MERCURY ENTERPRISES, INC.

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use
Primary Device ID10641043558676
NIH Device Record Key34e08df7-6999-4a5d-adb2-efc914a6cbf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyperinflation System
Version Model Number10-55867
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 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
GS110641043558676 [Primary]
GS130641043558670 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHKResuscitator,Manual,Non Self-Inflating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2018-09-19

On-Brand Devices [Hyperinflation System]

3064104355869410-55869
3064104355868710-55868
1064104355867610-55867
3064104355866310-55866
3064104355864910-55864
3064104355863210-55863
3064104355862510-55862
3064104355861810-55861
3064104355860110-55860
3064104355858810-55858
3064104355857110-55857
3064104355856410-55856
3064104355855710-55855
3064104355854010-55854
3064104355853310-55853
3064104355848910-55848
3064104355847210-55847
3064104355846510-55846
3064104355845810-55845
3064104355844110-55844
3064104355843410-55843
3064104355842710-55842
3064104355841010-55841
3064104355840310-55840
3064104355839710-55839
3064104355838010-55838
3064104355837310-55837
3064104355836610-55836
3064104355835910-55835
3064104355834210-55834
3064104355833510-55833
3064104355832810-55832
3064104355831110-55831
3064104355830410-55830
3064104355829810-55829
3064104355828110-55828
3064104355827410-55827
3064104355826710-55826
3064104355824310-55824
3064104355823610-55823
3064104355822910-55822
3064104355821210-55821
3064104355820510-55820
3064104355819910-55819
3064104355818210-55818
3064104355817510-55817
3064104355816810-55816
3064104355815110-55815
3064104355814410-55814
3064104355813710-55813

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