FDA.report

Dual VarioVac B/OR Rail

Primary DI
04048675389293
Brand
Dual VarioVac B/OR Rail
Company
Drägerwerk AG & Co. KGaA
Model
MP00516
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675389293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675389293040486753892934048675389293

GMDN Terms

TermDefinition
General-purpose suction system, pneumaticAn assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.

Sterilization Methods

Method

Contacts

PhoneEmail
+494518820info@draeger.com

Regulatory Flags

DUNS number
315578914
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04048675558736Filter SafeStar 55 PlusMP057902023-01-09
04048675665762Filter SafeStar 90 PlusMP057852023-01-09
04048675665786Filter SafeStar 60A PlusMP057952023-01-09
04048675665823Filter/HME TwinStar HEPA PlusMP058012023-01-09
04048675253426Mask NovaStarTS,NIV,w/SE,LMP015812015-10-24
04048675253402Mask NovaStarTS,NIV,w/SE,SMP015792015-10-24
04048675253419Mask NovaStarTS,NIV,w/SE,MMP015802015-10-24
04048675379300IBP Cable Utah26064912026-01-07
04048675557722IBP Adapter Cable Dräger 7pin26075582026-01-07
04048675379072IBP cable Becton Dickinson26064882026-01-06
04048675379089IBP Cable Abbott, Medex26064902026-01-06
04048675379096IBP cable Edwards26064892026-01-06
04048675557739IBP Adapter Cable Drager 10pin26075592026-01-06
04048675428909ThermoTrace_Peripheral_5pcsMX110012015-10-24
04048675428916ThermoTrace Core (5pcs)MX110002015-10-24

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