FDA.reportPublic FDA data

Fabius OS

Primary DI
04048675398240
Brand
Fabius OS
Company
Drägerwerk AG & Co. KGaA
Model
8608300
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSZGas-Machine, Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSZGas-Machine, AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011404000FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GSDraeger Medical, Inc.2002-02-22BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675398240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675398240040486753982404048675398240

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation, general-purposeAn assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).

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
04048675429302Scio Four, Oxi plus68718012015-11-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814905021400Codonics Safe Label System®(SLS) 610i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170CCODONICS INC.BSZ2026-04-20
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEMPARKER-HANNIFIN CORPORATIONBSZ2025-09-24
00810085200130Ultra PC% Oral Surgery Package HACCUTRON, INC.BSZ2025-05-14
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAADVANCED INSTRUMENTATIONS, INC.BSZ2025-02-07
05051977000857PenlonPENLON LTDBSZ2024-12-06
06936415980702A3 Anesthesia Delivery SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.BSZ2024-11-20
00852087007881Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00852087007898Infinium Medical Inc.INFINIUM MEDICAL, INC.BSZ2024-05-06
00816711024439DIGITAL MDM ASSY-120V(STAND MTPARKER-HANNIFIN CORPORATIONBSZ2024-04-05
00813830026979FRU, Gauge Newport O2ACCUTRON, INC.BSZ2023-10-05
00813830021141Flowmeter, CMACCUTRON, INC.BSZ2023-09-21
00813830027785Flowmeter, Digital FlushMount, INTACCUTRON, INC.BSZ2023-09-21
04048675556169Atlan A300 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556176Atlan A350Drägerwerk AG & Co. KGaABSZ2023-09-21
04048675556183Atlan A350 XLDrägerwerk AG & Co. KGaABSZ2023-09-21
04048675556343Atlan A300Drägerwerk AG & Co. KGaABSZ2023-09-21
00813830026986FRU, Gauge Newport N2OACCUTRON, INC.BSZ2023-09-15
00813830026993FRU, Gauge Newport Int O2ACCUTRON, INC.BSZ2023-09-15
00813830024579Chair Conversion KitACCUTRON, INC.BSZ2023-09-14
00813830023626Ultra PC % Pkg B, InternationalACCUTRON, INC.BSZ2023-09-13
0081383002458656800 Chair Conversion KitACCUTRON, INC.BSZ2023-09-13
00813830027402Ultra PC % Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027419Ultra DC Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027426Digital Ultra Package C ADJSACCUTRON, INC.BSZ2023-09-13
00813830027709Digital Ultra Flushmount Package G, INTACCUTRON, INC.BSZ2023-09-13
00813830028195Digital Ultra Package C, InternationalACCUTRON, INC.BSZ2023-09-13
00813830028522Digital Ultra Package F, UKACCUTRON, INC.BSZ2023-09-13