PEGASUS

Basic Information

• Brand Name: PEGASUS
• Primary DI: 00612223063016
• Version / Model: P6300
• Catalog Number: P6300
• Company Name: PEGASUS RESEARCH CORPORATION
• Labeler DUNS: 185432994
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-17
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: e9dd8520-a35b-4a62-9265-159b6c07d465

Device Description

FLO2 STANDARD FLOW OXYGEN DILUTER, PEDIATRIC KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	868.5600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12875	Oxygen administration tubing	A length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00612223063009	GS1	CS	10	In Commercial Distribution
Primary	00612223063016	GS1

Device Sizes

Type	Value	Unit	Text
Length	6	Feet
Outer Diameter	2	Inch
Weight	.4	Pound