DEVICE: Universal Holder assy (07325710004289)
Device Identifier (DI) Information
Universal Holder assy
6880068
In Commercial Distribution
Maquet Critical Care AB
6880068
In Commercial Distribution
Maquet Critical Care AB
No description.
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? |
---|---|---|---|---|
42411 | Neonatal/adult intensive-care ventilator |
A 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).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBK | Ventilator, Continuous, Facility Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K151814 | 000 |
K180098 | 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
85885a69-9024-45ea-821d-727d2fe7c3b8
May 28, 2019
4
January 29, 2016
May 28, 2019
4
January 29, 2016
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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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
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