FDA.report

Draeger Pendula

Primary DI
04048675302605
Brand
Draeger Pendula
Company
Drägerwerk AG & Co. KGaA
Model
G16808
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048675302605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048675302605040486753026054048675302605

GMDN Terms

TermDefinition
Image display monitor mountA dedicated mount onto which a visual display unit (VDU), e.g., a patient monitor, can be placed and secured so that it is safely mounted in a position suitable for viewing. This device will provide for adequate vertical and horizontal adjustment possibilities and will be manufactured for hospital use. In some situations a television set may be mounted instead. It will typically be affixed to a wall, ceiling, or the top of, or into, a medical device or system.

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
true
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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04048675034643Connector M34X1.5, 9/162M866802026-02-04
04048675034735Adapter 9/16" to 6mmMP004162026-02-04
04048675013532CORRUGATED BELLOWS K84100792015-10-24
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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