FDA.reportPublic FDA data

Gold Edition Carbon Dioxide Analyzer

Primary DI
00850644007008
Brand
Gold Edition Carbon Dioxide Analyzer
Company
Vacumed
Model
17515
Catalog number
17515
Device description
CO2 Analyzer
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
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973544000VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZERVacumed, Div. of Vacumetrics, Inc.1998-05-26CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850644007008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850644007008008506440070088506440070080850644007008

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide monitorA mains electricity (AC-powered) device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture through a particular method (e.g., electrochemical, infrared absorption, gas chromatographic, mass spectrometric) to determine a patient's ventilatory, circulatory, or metabolic status. It is typically used to measure end-tidal carbon dioxide (EtCO2) in expiratory gases during the administration of anaesthesia or during bedside monitoring. Commonly known as a capnograph or a capnometer, the sampling method can be "mainstream" and/or "sidestream".

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850644007169Disposable Mouthpiece 19mm OD1020-2501020-2502018-08-17
00850644007176Disposable Mouthpiece 19mm OD1020-1001020-1002018-08-17
00850644007206Disposable Mouthpiece 22mm OD1021-1001021-1002018-08-17
00850644007213Disposable Mouthpiece 22mm OD1021-2501021-2502018-08-24
00850644007220Disposable Mouthpiece 35mm OD1027-1001027-1002018-08-24
00850644007237Disposable Mouthpiece 35mm OD1027-2501027-2502018-08-24
00850644007244Disposable Mouthpiece 35mm OD1026-1001026-1002018-08-24
00850644007251Disposable Mouthpiece 35mm OD1026-2501026-2502018-08-24
00850644007268Disposable Mouthpiece 30mm OD1025-1001025-1002018-08-17
00850644007275Disposable Mouthpiece 30mm OD1025-2501025-2502018-08-24
00850644007282Disposable Mouthpiece 29mm OD1024-1001024-1002018-08-24
00850644007299Disposable Mouthpiece 29mm OD1024-2501024-2502018-08-24
00850644007305Pediatric mouthpiece 100/bx1004-BULK1004-BULK2018-08-24
00850644007312Disposable Mouthpiece 27mm OD1023-2501023-2502018-08-24
00850644007329Disposable Mouthpiece 26mm OD1022-1001022-1002018-08-24
00850644007336Disposable Mouthpiece 26mm OD1022-2501022-2502018-08-24
00850644007343Snuffer noseclip 100/bx100810082018-08-24
00850644007350Disposable Mouthpiece 22mm OD1021-BULK1021-BULK2018-08-17
00850644007367Disposable Mouthpiece 19mm OD1020-BULK1020-BULK2018-08-17
00850644007374Disposable Mouthpiece 35mm OD1027-BULK1027-BULK2018-08-17

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Primary DI, Brand, Company table
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