AnapnoGuard™ Endotracheal Tube 8.0mm

Basic Information

• Brand Name: AnapnoGuard™ Endotracheal Tube 8.0mm
• Primary DI: 07290015409162
• Version / Model: AnapnoGuard™ Endotracheal Tube 8.0mm
• Catalog Number: ETP80PUC1
• Company Name: HOSPITECH RESPIRATION LTD
• Labeler DUNS: 514824387
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-05
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: c7c71d83-563a-4c69-b616-642c290f2dca

Device Description

The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.

Device Characteristics

• Single Use: Yes
• 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
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46967	Basic endotracheal tube, single-use	A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290015409166	GS1	carton	100	In Commercial Distribution
Primary	07290015409162	GS1
Package	17290015409169	GS1	carton	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093126	000

Storage Conditions

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