AG Connection KIT

Basic Information

• Brand Name: AG Connection KIT
• Primary DI: 07290015409117
• Version / Model: AG Connection KIT
• Catalog Number: AG100SHRNS1
• Company Name: HOSPITECH RESPIRATION LTD
• Labeler DUNS: 514824387
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-23
• Public Version: 2
• Public Version Date: 2019-04-03
• Public Version Status: Update
• Public Device Record Key: 4b48729f-32ab-4276-9824-f212dd2f76a7

Device Description

AG Connection KIT is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.

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: MR Unsafe
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	868.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64188	Endotracheal tube intubation-management system	An electrically-powered, multi-purpose device assembly intended to sustain effective intubation of a patient using an endotracheal (ET) tube by: 1) inflating, monitoring, and maintaining inflation of the ET tube cuff; and 2) providing subglottic irrigation and aspiration; it may in addition be used for general-purpose airway clearance. It consists of an inflation pump, a pressure monitor, a carbon dioxide (CO2) sensor (to measure CO2 leaks around the cuff), an irrigation pump, a suction pump, and integrated controller.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290015409114	GS1	carton	10	In Commercial Distribution
Primary	07290015409117	GS1
Package	27290015409111	GS1	carton	40	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -32 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -32 – 104 Degrees Fahrenheit