DEVICE: SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O (04716770244204)
Device Identifier (DI) Information
SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60CM H2O
RE-24420
In Commercial Distribution
BESMED HEALTH BUSINESS CORP.
RE-24420
In Commercial Distribution
BESMED HEALTH BUSINESS CORP.
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? |
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36086 | Pulmonary resuscitator, manual, single-use |
A non-sterile, 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 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 single-use 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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K021442 | 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
e5128cbb-63da-48e3-ad1a-b82c99a02643
July 06, 2018
3
May 23, 2016
July 06, 2018
3
May 23, 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
[?]
No Customer Contact currently defined