Patient Circuit - Pediatric, 2.4m, 1 pcs

Basic Information

• Brand Name: Patient Circuit - Pediatric, 2.4m, 1 pcs
• Primary DI: 07290017096902
• Version / Model: VWSP-390
• Company Name: INOVYTEC MEDICAL SOLUTIONS LTD
• Labeler DUNS: 649213584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-11
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 66c2f44a-d0e3-446a-b722-2149e196f51c

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: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63534	Inspiratory/expiratory limb respiratory tubing, single-use	A length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and/or with other separate gas delivery devices (e.g., inhalational analgesia gas administration set, respiratory mask); connectors may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017096902	GS1
Package	17290017096909	GS1		15	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K202970	000