Precision Medical Inc.

Basic Information

• Brand Name: Precision Medical Inc.
• Primary DI: 00855887006924
• Version / Model: PM500
• Company Name: Precision Medical, Inc.
• Labeler DUNS: 112569116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-27
• Public Version: 3
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 3d3493ae-4e5f-4aa8-810e-ba0f2589ccaf

Device Description

Humidifier

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: No
• PM Exempt: No
• 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
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	868.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60856	Oxygen administration kit	A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855887006924	GS1
Package	00855887006931	GS1	CASE	50	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K902970	000