FDA.reportPublic FDA data

Vapor 3000

Primary DI
04048675301363
Brand
Vapor 3000
Company
Drägerwerk AG & Co. KGaA
Model
M36500
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
CADVaporizer, Anesthesia, Non-Heated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CADVaporizer, Anesthesia, Non-HeatedAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971923000DRAGER-VAPOR 2000Draeger Medical, Inc.1997-09-16CAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675301363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675301363040486753013634048675301363

GMDN Terms#

Term, Definition table
TermDefinition
Isoflurane anaesthesia vaporizerA device used to vaporize the anaesthetic agent isoflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.

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
06903053055000V80 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CAD2026-01-08
05051977001465PenlonPENLON LTDCAD2024-12-06
05051977002011PenlonPENLON LTDCAD2024-12-06
05051977002028PenlonPENLON LTDCAD2024-12-06
05051977002035PenlonPENLON LTDCAD2024-12-06
05051977002042PenlonPENLON LTDCAD2024-12-06
05051977001595PenlonPENLON LTDCAD2023-06-21
B005003320AincA®ANESTHESIA ASSOCIATES, INC.CAD2021-03-31
00840682124720TECDATEX-OHMEDA INCCAD2018-03-12
00840682124737TECDATEX-OHMEDA INCCAD2018-03-12
00840682124744TECDATEX-OHMEDA INCCAD2018-03-12
00840682124751TECDATEX-OHMEDA INCCAD2018-03-12
10620974002038Quik FilSouthmedic IncorporatedCAD2018-02-23
05051977000314Key Filler Bottle Adaptor MRIPENLON LTDCAD2017-08-01
05051977000536PenlonPENLON LTDCAD2017-07-18
05051977000444PenlonPENLON LTDCAD2017-02-14
10841522118135Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118173Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118258Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118265Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118326Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118357Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118371Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118401Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522119323Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106712Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522118234Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106774Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106736Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03
10841522106750Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCCAD2017-01-03