Vital Signs™

Basic Information

• Brand Name: Vital Signs™
• Primary DI: 10190752140899
• Version / Model: 900604-004
• Catalog Number: 900604-004
• Company Name: Vyaire Medical Oy
• Labeler DUNS: 368457563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-28
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 43d46043-47ee-4d91-b81f-2713470f835d

Device Description

Anesthesia B-Line and Straight Adapter, Disposable

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
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45566	Gas-sampling/monitoring respiratory tubing, single-use	A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20190752140896	GS1		50	In Commercial Distribution
Primary	10190752140899	GS1

Customer Contacts

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