FDA.reportPublic FDA data

Smart Lung 2000 2 Liter

Primary DI
07640214642363
Brand
Smart Lung 2000 2 Liter
Company
IMT Analytics AG
Model
302.730.100
Device description
Test lung (Physical simulator)
Published
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BTCBag, Reservoir

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640214642363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640214642363076402146423637640214642363

GMDN Terms#

Term, Definition table
TermDefinition
Lung physical simulatorA mechanical device intended to simulate/mimic the human lung(s) by imitating its physical properties. This device, commonly known as a test lung, may be a simple ventilation bag filled with foam rubber, or a complicated device, usually mechanical, that can be adjusted to imitate, e.g., change in compliance, airway restrictions, lung perforation. It is intended to be used by a healthcare provider in a clinical setting for the purpose of, e.g., maintenance, testing, user control of a ventilator and for the education of clinical staff.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480035934
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640214642837FlowMeter F1700.400.0012023-09-18
07640214642844FlowMeter F2700.400.0022023-09-18
07640214642851FlowMeter F1700.400.0012023-09-18
07640214642868FlowMeter F2700.400.0022023-09-18
07640214642400CITREX H4302.161.0002022-11-17
07640214642417CITREX H5304.555.0002022-11-17
07640214642448Flow Analyzer PF-300300.116.0002022-11-17
07640214642455Flow Analyzer PF-301300.116.0012022-11-17
07640214642462Flow Analyzer PF-302300.116.0022022-11-17
07640214642707Flow Analyzer PF-300 PRO700.300.0002022-11-17
07640214642370Smart Lung Adult 1 Liter300.162.1002022-11-17
07640214642387Smart Lung Infant 0.5 Liter300.400.1042022-11-17
07640214642394CITREX H3304.333.0002022-11-17
07640214641946CITREX H4302.161.0002022-11-17
07640214642165CITREX H5304.555.0002022-11-17
07640214641243Flow Analyzer PF-300300.116.0002022-11-17
07640214641250Flow Analyzer PF-301300.116.0012022-11-17
07640214641267Flow Analyzer PF-302300.116.0022022-11-17
07640214642691Easy Lung 1 Liter300.756.1002022-11-17
07640214642714Flow Analyzer PF-300 PRO700.300.0002022-11-17

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04816415501447BREATHING BAG single use 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501454BREATHING BAG single use 2000ASSOMEDIKA, OOOBTC2026-05-27
04816415501461BREATHING BAG single use 3000ASSOMEDIKA, OOOBTC2026-05-27
04816415501478BREATHING BAG reusable 500ASSOMEDIKA, OOOBTC2026-05-27
04816415501485BREATHING BAG reusable 1000ASSOMEDIKA, OOOBTC2026-05-27
04816415501492BREATHING BAG reusable 2000ASSOMEDIKA, OOOBTC2026-05-27
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