EM

Basic Information

• Brand Name: EM
• Primary DI: 00026072022207
• Version / Model: L599-140
• Company Name: Allied Medical, LLC
• Labeler DUNS: 119066872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-28
• Public Version: 2
• Public Version Date: 2025-10-13
• Public Version Status: Update
• Public Device Record Key: 2bb7ec07-c78e-411e-97ba-36ba66984264

Device Description

VENT CIRCUIT 10/CS MASK&EX FIL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
66527	Ventilator breathing circuit/mask	An assembly of devices that includes a breathing circuit and a respiratory mask designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient during noninvasive ventilation. It includes breathing tubes, a Y-piece connector, and typically provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40026072022205	GS1		10	In Commercial Distribution
Primary	00026072022207	GS1