Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 10885380175916
• Version / Model: CA28250
• Catalog Number: CA28250
• Company Name: Aero-Med, Ltd.
• Labeler DUNS: 194550042
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-18
• Public Version: 3
• Public Version Date: 2022-07-08
• Public Version Status: Update
• Public Device Record Key: 5cbab187-7cc6-4ebf-8422-ba8896843831
• Distribution End Date: 2022-07-08

Device Description

Blood Culture Collection Kit, Steripath 21G Gen2, Adult, McLaren Health Only

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380175914	GS1	CASE	50	Not in Commercial Distribution	2022-07-08
Primary	10885380175916	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius