Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 10885380193828
• Version / Model: CA44550A
• Catalog Number: CA44550A
• Company Name: Aero-Med, Ltd.
• Labeler DUNS: 194550042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-04
• Public Version: 2
• Public Version Date: 2023-01-10
• Public Version Status: Update
• Public Device Record Key: 1e2444d5-cf2d-43f1-9c91-de859b14b08e

Device Description

Kit Blood Culture Adult for Adventist Health - Tulare 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: 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: No
• 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	50885380193826	GS1	CASE	50	In Commercial Distribution
Primary	10885380193828	GS1

Storage Conditions

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