Vyaire

Basic Information

• Brand Name: Vyaire
• Primary DI: 34250892903973
• Version / Model: V-859142-13
• Catalog Number: V-859142-13
• Company Name: Vyaire Medical GmbH
• Labeler DUNS: 329769991
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-14
• Public Version: 3
• Public Version Date: 2021-03-16
• Public Version Status: Update
• Public Device Record Key: 4cb85043-498f-40f9-a711-ec0b02e43a97

Device Description

Vyntus CART Basic

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
BZC	Calculator, Pulmonary Function Data	Anesthesiology	868.1880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36416	Tissue embedding unit IVD	An electrically-powered, electronic unit intended to be used in the laboratory for encapsulating (embedding) histologic tissue samples in liquid paraffin wax which when cooled and fixed to a sample holder can be further processed, e.g., placed in a microtome for cutting into samples for microscopy and/or for histological storage. This device will typically have a large storage capacity for the liquid paraffin (e.g., 4 litres) with heating facilities and heated work area, excess paraffin drainage facility, a cold plate area, and possibly a built-in forceps heater.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	34250892903973	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183567	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity