Aero-Med

Basic Information

• Brand Name: Aero-Med
• Primary DI: 10810010892086
• Version / Model: QUE750
• Catalog Number: QUE750
• Company Name: Aero-Med, Ltd.
• Labeler DUNS: 194550042
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-03-27
• Public Version: 1
• Public Version Date: 2019-04-04
• Public Version Status: New
• Public Device Record Key: b5556cb1-2403-4ac6-ad99-86bb1874e6c4

Device Description

Specimen Container; Convenience Packaging

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
NNK	CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63233	General specimen transport medium collection kit, non-sterile	A collection of non-sterile devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (i.e., it is not dedicated to a body region)] for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], sometimes sterile, and a covered plastic receptacle containing a transport medium (e.g., cell or nucleic acid preservation solution, microbiological medium). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50810010892084	GS1	CASE	16	In Commercial Distribution
Primary	10810010892086	GS1
Unit of Use	70810010892088	GS1