Puritan Bennett

Basic Information

• Brand Name: Puritan Bennett
• Primary DI: 20884521210933
• Version / Model: 10047078
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-03
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: 2ab9e323-c3a6-49aa-9466-630d2d7ce45a

Device Description

Proximal Flow Sensor 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: 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: Yes
• 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
60778	Breathing circuit multi-parameter sensor	A device intended to be connected to a breathing circuit to transduce signals from respiratory gases to enable a parent device receiving the signals to measure multiple parameters of the respiratory gases (e.g., flow, temperature). It is in the form of a transducer connected to the parent monitoring/measuring device; the parent device will typically display the parameters it receives and may respond by making control adjustments. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521210936	GS1	CASE	10	In Commercial Distribution
Primary	20884521210933	GS1

Customer Contacts

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

Storage Conditions

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