Puritan Bennett

Basic Information

• Brand Name: Puritan Bennett
• Primary DI: 20884521139852
• Version / Model: 10005002
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-15
• Public Version: 3
• Public Version Date: 2023-08-15
• Public Version Status: Update
• Public Device Record Key: d5cd508f-c97d-40bb-9ae7-5ab97f6bbbb1

Device Description

Neonatal Flow and CO2 Sensor Disposable;For 980 Series Ventilator

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
BXP	TRANSDUCER, GAS FLOW	Anesthesiology	868.2885	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46821	Carbon dioxide cuvette, single-use	A 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 that is slotted over the outside of the window section. 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
Package	10884521139855	GS1	CASE	10	In Commercial Distribution
Primary	20884521139852	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry