FDA.reportPublic FDA data

IACS Workstation Critical Care

Primary DI
04048675042266
Brand
IACS Workstation Critical Care
Company
Drägerwerk AG & Co. KGaA
Model
8416400
Device description
Workstation composed of two main units: the ventilation unit (Evita V500) and the display/interface unit (C500). This combined configuration represents the actual product delivered to customers under this UDI.
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675042266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675042266040486750422664048675042266

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal/adult intensive-care ventilatorA mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).

Contacts#

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

Regulatory Flags#

DUNS number
315578914
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675594956Atlan A100 XL86212002026-08-03
04048675594963Atlan A10086211002026-08-03
04048675822363Babyroo TN300MU303002026-07-15
04048675795124Sample Line 2,5m68738502026-07-21
04048675824121Seattle PAPMP022542026-06-11
04048675001065OxyTrace IncuMX010502015-10-24
04048675016403Savina System84144502015-10-24
04048675017097Babytherm 8010 System2M223802015-10-24
04048675017165Caleo2M500002015-10-24
04048675041382Babytherm 8004 System2M223702015-10-24
04048675042174NBP Cuff L+, 31-40/55cm, Box10MP009322022-06-22
04048675251422Savina 30084178002015-10-24
04048675686712VentStar Resus heated (N)MP170302025-05-14
04048675686736VentStar AutoBreath heated (N)MP170312025-05-14
04048675641308Babyleo TN5002M611002026-03-23
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

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Primary DI, Brand, Company table
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