T-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVES

Basic Information

• Brand Name: T-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVES
• Primary DI: 05030267057153
• Version / Model: 1953000
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-06
• Public Version: 2
• Public Version Date: 2022-02-07
• Public Version Status: Update
• Public Device Record Key: e6947a26-eb58-47b9-8c21-ef6ee5aea09f

Device Description

T-PIECE, 22F, 22M, 22M WITH ONE-WAY VALVES

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZA	Connector, Airway (Extension)	Anesthesiology	868.5810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60657	Non-rebreathing valve, single-use	A non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05030267005116	GS1		100	In Commercial Distribution
Primary	05030267057153	GS1
Package	05030267005109	GS1		25	In Commercial Distribution

Customer Contacts

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