DEVICE: Innocor (05713867000124)
Device Identifier (DI) Information
Innocor
INN00100-1
In Commercial Distribution
Innovision ApS
INN00100-1
In Commercial Distribution
Innovision ApS
Innocor Cardio-pulmonary function test equipment
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 36134 | Pulmonary function analysis system, paediatric |
A computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and resistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures required for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for plethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital capacity, forced expiratory volume) can't be determined. The device is used for pulmonary function testing in diagnostic studies and for evaluation of diseases and chest deformities.
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Active | false |
| 35282 | Pulmonary function analysis system, adult |
A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].
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Active | false |
| 36146 | Cardiopulmonary stress exercise monitoring system |
An assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DQK | Computer, Diagnostic, Programmable |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K051907 | 000 |
| K071911 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
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| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
ad215349-2f48-41b1-96a7-0779353c75ff
July 06, 2018
3
March 14, 2017
July 06, 2018
3
March 14, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined