Emergent Respiratory

Basic Information

• Brand Name: Emergent Respiratory
• Primary DI: 00850071887280
• Version / Model: 35100-100
• Company Name: MDL Solutions Incorporated
• Labeler DUNS: 117921082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-11
• Public Version: 1
• Public Version Date: 2026-02-19
• Public Version Status: New
• Public Device Record Key: 2b9abd70-d54a-4997-b3ef-54dab1d99f15

Device Description

Standalone Circuit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37706	Ventilator breathing circuit, single-use	An assembly of devices 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 artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850071887297	GS1	Pack	5	In Commercial Distribution
Primary	00850071887280	GS1
Package	00850071887303	GS1	Pack	10	In Commercial Distribution
Package	00850071887310	GS1	Pack	50	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021520	000