Airway Adapters

Basic Information

• Brand Name: Airway Adapters
• Primary DI: 00884838104792
• Version / Model: 1149448
• Catalog Number: 1149448
• Company Name: Respironics Novametrix, LLC
• Labeler DUNS: 093608594
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-15
• Public Version: 5
• Public Version Date: 2025-06-23
• Public Version Status: Update
• Public Device Record Key: ca797cae-cdaf-4a68-8cbd-7126a9d5cea1

Device Description

Neonatal/Pediatric Airway Adapter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZA	CONNECTOR, AIRWAY (EXTENSION)	Anesthesiology	868.5810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838104792	GS1
Package	30884838104793	GS1		10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius