GAS MONITORING LINE 1.2MM ID, F LUER LOCK/M LUER LOCK, 1.8M

Basic Information

• Brand Name: GAS MONITORING LINE 1.2MM ID, F LUER LOCK/M LUER LOCK, 1.8M
• Primary DI: 05030267064922
• Version / Model: 2731000
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-18
• Public Version: 1
• Public Version Date: 2022-11-28
• Public Version Status: New
• Public Device Record Key: fc26dce7-37e3-424c-b575-acdaedef7a4a

Device Description

GAS MONITORING LINE 1.2MM ID, F LUER LOCK/M LUER LOCK, 1.8M

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

GMDN Terms

Code	Name	Definition	Implantable	Status
61832	Gas-sampling/monitoring respiratory tubing, reusable	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 reusable device intended to be cleaned/disinfected prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05030267011797	GS1		20	In Commercial Distribution
Primary	05030267064922	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122075	000