FDA.reportPublic FDA data

Evita VPack inv w CO2 Cuvette

Primary DI
04048675421153
Brand
Evita VPack inv w CO2 Cuvette
Company
Drägerwerk AG & Co. KGaA
Model
MP01656
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675251194PackageGS15In Commercial Distribution
04048675421153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675251194040486752511944048675251194
04048675421153040486754211534048675421153

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial medical gas filterA device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+494518820info@draeger.com

Regulatory Flags#

DUNS number
315578914
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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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

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Primary DI, Brand, Company table
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