FDA.reportPublic FDA data

MIB II PROTOCOL CONVERTER

Primary DI
04049098053662
Brand
MIB II PROTOCOL CONVERTER
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
7256931
Published
2015-10-24
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
DRQAmplifier And Signal Conditioner, Transducer Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050974000DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERSDraeger Medical Systems, Inc.2005-04-29DRQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049098053662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049098053662040490980536624049098053662

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, interfacingA small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004372437info@draeger.com

Regulatory Flags#

DUNS number
788289952
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049098095778SHIP UNIT M300+MS336482025-02-19
04049098053785Infinity etCO2 SmartPod57407202015-10-24
04049098061858Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098041829Disposable Mechanical Ventilation CircuitMU047712025-12-10
04049098000406Breathing hose for Resuscitaire with AutoBreath, disposable, 25 pcs.MU108412015-10-24
04048675673408Gateway Software Server VF9.0.1MS405452025-02-19
04048675762256Gateway Software Server VF9.1.137347182025-02-19
04048675777762Gateway Software Server VF9.1.237363762025-02-19
04048675780212Infinity R50-S RecorderMS412172025-02-19
04049098001519Infinity M300 Bedside ChargerMS295582025-02-19
04049098007061Infinity Gateway USB DongleMS117002025-02-19
04049098095730Infinity M300+MS339502025-02-19
04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098099608Gateway Software Server VF9.0MS400482025-02-19
04049098001878Infinity CentralStation Wide (confi)MS268002015-10-24
04049098000185Resuscitaire Birthing Room Warmer (WBR82)MU205122015-10-24
04049098000192TI500 Globetrotter Neonatal Transport SystemMU205082015-10-24
04049098000215Resuscitaire Radiant Warmer (RW82, RW82 VHA)MU205032015-10-24
04049098000413Restraint strap, replacement, carton of 10MU060112015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04931921017159CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONDRQ2023-10-30
04931921017166CNS-2101 Central MonitorNIHON KOHDEN CORPORATIONDRQ2023-10-01
00868924000267Monitor Input Cable, Mikro-Cath to EP-Tracer SystemMILLAR INC.DRQ2021-07-16
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHDRQ2021-03-08
08714729882985LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729882992LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
08714729883234LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
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08714729885962LABSYSTEM™ PROBOSTON SCIENTIFIC CORPORATIONDRQ2019-12-13
40841716101586ACIST RXi® Mini System OverpackACIST MEDICAL SYSTEMS, INC.DRQ2019-05-06
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHDRQ2018-12-18
10841716101769ACIST RXi® Mini MountACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27
10841716101783ACIST RXi® Mini Processing UnitACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27
10841716101790ACIST RXi® Mini Navvus InterfaceACIST MEDICAL SYSTEMS, INC.DRQ2017-09-27