Cardiopulmonary stress exercise monitoring system

Primary DI
00850644007022
Brand
Cardiopulmonary stress exercise monitoring system
Company
Vacumed
Model
17590 REV2-YD
Catalog number
YD17590
Device description
Vista Interface System
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZLCOMPUTER, OXYGEN-UPTAKE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZLComputer, Oxygen-UptakeAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864852000VISTA INTERFACE SYSTEMVacumetrics, Inc.1987-03-04BZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850644007022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850644007022008506440070228506440070220850644007022

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary stress exercise monitoring systemAn assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)235-3333info@vacumed.com

Regulatory Flags#

DUNS number
077967081
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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00850644007275Disposable Mouthpiece 30mm OD1025-2501025-2502018-08-24
00850644007282Disposable Mouthpiece 29mm OD1024-1001024-1002018-08-24
00850644007299Disposable Mouthpiece 29mm OD1024-2501024-2502018-08-24
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