Vital Signs

Basic Information

• Brand Name: Vital Signs
• Primary DI: 50885403293465
• Version / Model: 5108PE
• Catalog Number: 5108PE
• Company Name: Carefusion Corporation
• Labeler DUNS: 830432451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1500
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 90b8d362-a73d-4e2a-9a21-0bd1ec70e630

Device Description

Vital Signs&#8482 Fresh Gas Elbow

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: No
• 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
CAH	Filter, bacterial, breathing-circuit	Anesthesiology	868.5260	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
Primary	50885403293465	GS1
Unit of Use	10885403293467	GS1

Customer Contacts

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