Emergent Respiratory

Basic Information

• Brand Name: Emergent Respiratory
• Primary DI: 00850071887129
• Version / Model: 1900-123
• Company Name: MDL Solutions Incorporated
• Labeler DUNS: 117921082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-05
• Public Version: 1
• Public Version Date: 2025-04-14
• Public Version Status: New
• Public Device Record Key: 1ff21bd4-a675-4f67-8f2b-f11c54b81dc6

Device Description

Breathing Circuit with Small S3 Mask

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
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	00850071887136	GS1	Pack	5	In Commercial Distribution
Primary	00850071887129	GS1
Package	00850071887143	GS1	Pack	10	In Commercial Distribution
Package	00850071887150	GS1	Pack	50	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021520	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Small