MicroAire®

Basic Information

• Brand Name: MicroAire®
• Primary DI: 00847399006639
• Version / Model: CAP-200
• Company Name: Microaire Surgical Instruments LLC
• Labeler DUNS: 103056420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-17
• Public Version: 1
• Public Version Date: 2022-09-26
• Public Version Status: New
• Public Device Record Key: 2f14b295-7f9e-48f6-a8eb-6d124595ce7d

Device Description

WASHER DISINFECTOR CAP, HALL STYLE CONNECTOR

Device Characteristics

• Single Use: No
• 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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63884	Surgical instrument protective cap	A small, non-sterile cover designed to be placed on the tip or working end of a surgical instrument to protect it from damage while not in use. It may be made of metal or synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847399006639	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -18 – 49 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 91 Percent (%) Relative Humidity