Gold Edition O2 Analyzer

Primary DI
00850644007015
Brand
Gold Edition O2 Analyzer
Company
Vacumed
Model
17518
Catalog number
17518
Device description
O2 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
CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973545000VACU*MED GOLD EDITION OXYGEN GAS ANALYZERVacumed, Div. of Vacumetrics, Inc.1998-05-26CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850644007015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850644007015008506440070158506440070150850644007015

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen breath analyserA mains electricity (AC-powered) laboratory instrument designed for intermittent/periodic measurements of oxygen (O2) content in a breath and/or respiratory gas specimen. It usually requires manual aspiration of a quantity of gas into a sampling chamber and may operate according to one of several basic principles (e.g., paramagnetism, polarography). The device is used in pulmonary function tests and for measurements in critically ill patients, such as infants in incubators and patients breathing air with supplemental oxygen.

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
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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
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