DEVICE: Allied Healthcare Products Inc. (00260720000036)
Device Identifier (DI) Information
Allied Healthcare Products Inc.
AHP300-CAF
In Commercial Distribution
AHP300-CAF
ALLIED HEALTHCARE PRODUCTS, INC.
AHP300-CAF
In Commercial Distribution
AHP300-CAF
ALLIED HEALTHCARE PRODUCTS, INC.
Transport Ventilator with Internal Compressor
Device Characteristics
MR Unsafe | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Transport electric ventilator | An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTL | Ventilator, Emergency, Powered (Resuscitator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132021 | 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
1b3a58da-c4e6-4fbf-bc98-68784b42c063
July 06, 2018
3
November 20, 2015
July 06, 2018
3
November 20, 2015
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