Vista MX2 (Gold Edition) 17594G

GUDID 00850644007060

Vista Interface System

Vacumed

Cardiopulmonary stress exercise monitoring system
Primary Device ID00850644007060
NIH Device Record Key3c9c2af2-1182-4af9-9dd2-3199727ee24d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVista MX2 (Gold Edition)
Version Model Number17594G
Catalog Number17594G
Company DUNS077967081
Company NameVacumed
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)235-3333
Emailinfo@vacumed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850644007060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZLCOMPUTER, OXYGEN-UPTAKE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-14

Devices Manufactured by Vacumed

00850644007169 - Disposable Mouthpiece 19mm OD2020-03-23 cardboard mouthpiece
00850644007176 - Disposable Mouthpiece 19mm OD2020-03-23 cardboard mouthpiece
00850644007206 - Disposable Mouthpiece 22mm OD2020-03-23 cardboard mouthpiece
00850644007213 - Disposable Mouthpiece 22mm OD2020-03-23 cardboard mouthpiece
00850644007220 - Disposable Mouthpiece 35mm OD2020-03-23 cardboard mouthpiece
00850644007237 - Disposable Mouthpiece 35mm OD2020-03-23 cardboard mouthpiece
00850644007244 - Disposable Mouthpiece 35mm OD2020-03-23 cardboard mouthpiece
00850644007251 - Disposable Mouthpiece 35mm OD2020-03-23 cardboard mouthpiece

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.