Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 10885380183386
• Version / Model: CA33525
• Catalog Number: CA33525
• Company Name: Aero-Med, Ltd.
• Labeler DUNS: 194550042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-23
• Public Version: 1
• Public Version Date: 2020-12-01
• Public Version Status: New
• Public Device Record Key: 3144c0ed-9d9e-47b7-a864-3ebf7678a330

Device Description

Virtuwell STD Specimen Collection Kit, Health Partners Minneapolis

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIB	Blood and urine collection kit (excludes HIV testing)	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60889	Specimen mailer kit	A collection of items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form, and a specimen container mailer. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380183384	GS1	CASE	10	In Commercial Distribution
Primary	10885380183386	GS1