DEVICE: NeoPod T, Neonatal Transport Humidification System (00850018561648)
Device Identifier (DI) Information
NeoPod T, Neonatal Transport Humidification System
9400
In Commercial Distribution
9400
INTERNATIONAL BIOMEDICAL, LTD.
9400
In Commercial Distribution
9400
INTERNATIONAL BIOMEDICAL, LTD.
Neonatal Transport Humidification System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
No | |
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No |
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? |
---|---|---|---|---|
12050 | Heated respiratory humidifier |
A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K870173 | 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
de023894-433b-461a-b31c-c98a2845d05d
June 28, 2023
1
June 20, 2023
June 28, 2023
1
June 20, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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
[?]
5128730033
sales@int-bio.com
sales@int-bio.com