DEVICE: NeoNatalie Complete Dark (US) (07045432001921)
Device Identifier (DI) Information
NeoNatalie Complete Dark (US)
104-10003
In Commercial Distribution
104-10003
Laerdal Medical AS
104-10003
In Commercial Distribution
104-10003
Laerdal Medical AS
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
This kit includes NeoNatalie Resuscitator filed as DI 07045432066333 in GUDID
Device Characteristics
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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? |
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17591 | Pulmonary resuscitator, manual, reusable |
A hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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BTM | Ventilator, Emergency, Manual (Resuscitator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K132172 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between -18 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
63f1497e-e515-4782-90a1-8531bdf90e18
July 06, 2018
3
September 09, 2016
July 06, 2018
3
September 09, 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
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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
[?]
(877) 523-7325
cutomerservice@laerdal.com (800)431-1055
customerservice@laerdal.com
cutomerservice@laerdal.com (800)431-1055
customerservice@laerdal.com