DEVICE: Airway Adapter (00884838014053)

Device Identifier (DI) Information

Airway Adapter
6421-00
In Commercial Distribution
6421-00
Respironics Novametrix, LLC
00884838014053
GS1

1
093608594 *Terms of Use
Pediatric/Adult Airway Adapter with Mouthpiece
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

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?
46821 Carbon dioxide cuvette, single-use
A non-electrical device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor [not included] that is slotted over the outside of the window section; some types may additionally feature an adaptor for the acceptance of a gas flow sensor. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BZA CONNECTOR, AIRWAY (EXTENSION)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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

9e56207b-22be-484d-b99b-8590b586a9d7
June 23, 2025
5
September 14, 2020
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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
30884838014054 10 00884838014053 In Commercial Distribution
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Secondary DI

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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(724)744-2500
Respironics.Service@philips.com
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