LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL

Basic Information

• Brand Name: LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL
• Primary DI: 00840117333420
• Version / Model: 8023
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-04-07
• Public Version: 2
• Public Version Date: 2025-05-05
• Public Version Status: Update
• Public Device Record Key: 5f9c0c61-db47-41c6-9c7f-efa844f0a199

Device Description

Non-Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Expiration Date: No
• 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
NNI	Container, Specimen, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63807	Breath specimen container adaptor IVD	A device designed to facilitate the connection of a breath specimen container (e.g., bag) to a breath specimen analyser to facilitate the transfer of the specimen into the analyser, for in vitro diagnostic investigation. It is in the form of a small cylinder with mating ends, typically containing an adsorption medium (e.g., silica granules) for transferring specific compounds [e.g., aldehydes]. This is a single-use device.	No	Active
66899	Contaminated waste bag	A flexible plastic pouch intended for the safe collection, storage, transportation and disposal of contaminated and/or otherwise hazardous biological materials, typically containing or having been in contact with bodily substances such as blood, sputum, urine, faeces; it is not intended for in vitro diagnostic purposes. It is typically identified with the biohazard symbol on its labelling and may be colour coded. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810180841672	GS1
Primary	00840117333420	GS1