Respironics

Basic Information

• Brand Name: Respironics
• Primary DI: 00884838013902
• Version / Model: 3473INF-00
• Catalog Number: 3473INF-00
• Company Name: Respironics Novametrix, LLC
• Labeler DUNS: 093608594
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-14
• Public Version: 3
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: cdb0e9de-ac07-4e86-b1bd-46e29a48ef29

Device Description

LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42049	Gas dehumidification tubing set, single-use	A collection of devices intended to be used for the purpose of dehumidifying exhaled gas prior to its analysis in a gas analyser. It is composed of a length of hollow tubing made from one of several malleable or semi-rigid materials (e.g., silicone, plastic, rubber or nylon) and an integrated filter which absorbs (subtracts) the humidity from the gases before they enter the analysing chamber of the parent device. It has a limited lifetime and may be exchanged by the user, in which case it will typically be located on the outside of the parent device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838013902	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius