DEVICE: Oval Silicone ResuscitatorPediatric (05707480039845)
Device Identifier (DI) Information
Oval Silicone ResuscitatorPediatric
370004000
In Commercial Distribution
370004000
Ambu A/S
370004000
In Commercial Distribution
370004000
Ambu A/S
Ambu Oval Silicone Resuscitator, Pediatric. Complete with patient valve, pressure limiting valve, O2 reservoir bag and transparent silicone face mask size 0.
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? |
---|---|---|---|---|
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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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Handling Environment Temperature: between -18 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Pediatric |
Device Record Status
d7b6c7ce-a90b-47d3-ad49-9e949a9705e9
March 29, 2018
2
December 19, 2016
March 29, 2018
2
December 19, 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 |
---|---|---|---|---|---|
05707480039852 | 12 | 05707480039845 | In Commercial Distribution |
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
[?]
+14107686464
Purchase_orders@ambuUSA.com
Purchase_orders@ambuUSA.com