3100B HFOV 11744-HRCK

GUDID 50190752158915

3100B Disposables Kit, Box of 4 / HRC

VYAIRE MEDICAL, INC.

Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use
Primary Device ID50190752158915
NIH Device Record Key3041c5e0-7a19-408c-9cf2-a592ec0cb3de
Commercial Distribution StatusIn Commercial Distribution
Brand Name3100B HFOV
Version Model Number11744-HRCK
Catalog Number11744-HRCK
Company DUNS080456871
Company NameVYAIRE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com
Phone+1(833)327-3284
Emailcustomersupport@vyaire.com

Device Identifiers

Device Issuing AgencyDevice ID
GS150190752158915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSZVENTILATOR, HIGH FREQUENCY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-13
Device Publish Date2021-05-05

On-Brand Devices [3100B HFOV]

10190752158993Flexible Patient Circuit w/Filter for 3100B (FP850)
101907521586273100B VENT ASSY, DOMESTIC
101907521554423100B VENT ASSY,220V/50HZ
50190752159905Flexible Patient Circuit w/Filter for 3100B (HRCI)
50190752159899Flexible Patient Circuit w/Filter for 3100B (FP850)
50190752159882Flexible Patient Circuit w/Filter for 3100B (FP730)
501907521598753100B Disposables Kit, Box of 4 / HRC
501907521598683100B Disposables Kit, Box of 4 / F&P 850
501907521598513100B Disposables Kit, Box of 4 / F&P 730
501907521589153100B Disposables Kit, Box of 4 / HRC
501907521575673100B Disposables Kit, Box of 4 / F&P 850
501907521551503100B Disposables Kit, Box of 4 / F&P 850
101907521588253100B Disposable Items Kit / F&P 850
101907521588183100B Disposable Items Kit / F&P 730
101907521588013100B Disposable Items Kit / HRCI
50190752159004Flexible Patient Circuit w/Filter for 3100B (HRCI)
50190752158984Flexible Patient Circuit w/Filter for 3100B (FP730)

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