FDA.reportPublic FDA data

IACS Workstation Neonatal Care

Primary DI
04048675250418
Brand
IACS Workstation Neonatal Care
Company
Drägerwerk AG & Co. KGaA
Model
8417400
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093632000INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CAREDrager Medical AG & Co. Kgaa2010-04-05CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675250418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675250418040486752504184048675250418

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal intensive-care ventilatorA mains electricity (AC-powered) automatic cycling device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient, especially those preterm and critically ill with respiratory failure in a critical care setting. It is typically a time-cycled, pressure-control device that includes a small bore flexible tube breathing system. It may be capable of high frequency oscillatory ventilation in addition to conventional ventilation, and includes positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) controls.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315578914
Device count
1
Serial number
true
Manufacturing date on label
true

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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00198843001145bellavistaZoll Medical CorporationCBK2026-06-24
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10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
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