FDA.reportPublic FDA data

Scio Four, Oxi plus

Primary DI
04048675429302
Brand
Scio Four, Oxi plus
Company
Drägerwerk AG & Co. KGaA
Model
6871801
Published
2015-11-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051628000INFINITY MONITORS WITH SCIO MODIFICATIONSDraeger Medical Systems, Inc.2005-07-20MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675429302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675429302040486754293024048675429302

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthetic agent gas monitor, multipleA mains electricity (AC-powered) instrument designed for the continuous and simultaneous sampling, measuring, and display of concentrations of more than one gaseous anaesthetic agent (e.g., halothane, desflurane, Ethrane, isoflurane) in a breathing system (e.g., at an anaesthetic unit/workstation outlet or from a bedside breathing/sampling system), to ensure that appropriate agent levels are administered to a patient. It may also measure inspired and/or expired oxygen (O2) and/or carbon dioxide (CO2). Methods to determine gas concentrations include infrared (IR) spectrometry, ultraviolet (UV) absorption, interferometry, and ultrasound.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494518820info@draeger.com

Regulatory Flags#

DUNS number
315578914
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675542148Evita V80084225002023-06-02
04048675548744Evita V60084223002023-06-02
04048675641308Babyleo TN5002M611002026-03-23
04048675448884Sample Line Set (10pcs)82902862026-02-16
04048675034643Connector M34X1.5, 9/162M866802026-02-04
04048675034735"Adapter 9/16"" to 6mm"MP004162026-02-04
04048675229674Apollo86065002015-10-24
04048675429319Scio Four, plus68718022015-11-04
04048675429326Scio Four, Oxi68718032015-11-04
04048675420989APack Watertrap AdultMP016822015-10-24
04048675013532CORRUGATED BELLOWS K84100792015-10-24
04048675010470Corrugated hose 10/10 (N/P) 1984107092015-10-24
04048675022305Hytrel hose 13/13 (N/P) 6584108142015-10-24
04048675041061Headgear disp.,soft rub.,smallMP015612015-10-24
04048675041078Headgear disp.,soft rub.,largeMP015622015-10-24
04048675126317AnesthesiaSet Flex Latexfrei USMP003232015-10-24
04048675253365VentStar Helix dual heatedMP026062015-10-24
04048675253372VentStar Helix heatedMP026072015-10-24
04048675382256Mask ventkit O2Star fixed M/LMP019232015-10-24
04048675382423Mask ventkit O2Star fixed SMP019362015-10-24

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Primary DI, Brand, Company table
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