DEVICE: Remote Alarm (00606959023642)

Device Identifier (DI) Information

Remote Alarm
0
In Commercial Distribution
1120632
Respironics, Inc.
00606959023642
GS1
December 31, 9999
1
080728314 *Terms of Use
Remote Alarm International
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Device Characteristics

MR Safe
No
No
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
Airway pressure alarm A battery-powered warning device that monitors a patient's upper airway pressure during assisted mechanical ventilation; it typically being connected to the breathing circuit. In the event of either the pressure not rising above a minimum threshold within a maximum time span or exceeding a pre-set maximum level, the device will signal a warning.
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FDA Product Code

[?]
Product Code Product Code Name
CBK VENTILATOR, CONTINUOUS, FACILITY USE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

03868487-157c-4661-89c6-d193277caf15
March 29, 2018
2
November 02, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(724)744-2500
respironics.service@philips.com
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