Atmos

Basic Information

• Brand Name: Atmos
• Primary DI: 00850030696045
• Version / Model: Single Sensor Coudé Bladder Air-Charged Urodynamics Catheter
• Catalog Number: 1CB-AC
• Company Name: Gemini Medical Technologies LLC
• Labeler DUNS: 125832371
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-28
• Public Version: 1
• Public Version Date: 2024-06-05
• Public Version Status: New
• Public Device Record Key: e4863f38-e5c2-4566-811b-fa94aa3d668f

Device Description

For Bladder Pressure

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62244	Urodynamic manometric catheter, non-electronic	A sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed is typically the infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in urodynamic examination equipment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850030696045	GS1
Package	10850030696059	GS1		100	In Commercial Distribution

Customer Contacts

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