Atmos

Basic Information

• Brand Name: Atmos
• Primary DI: 08032248487147
• Version / Model: UD-A58245
• Company Name: DELTA MED SPA
• Labeler DUNS: 444776777
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-02
• Public Version: 1
• Public Version Date: 2025-09-10
• Public Version Status: New
• Public Device Record Key: a61d1c30-cd8b-4da3-a29c-b26afd5e0dde

Device Description

Pump Tubing 5x8mm

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXQ	Cystometer, Electrical Recording	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14301	Urological irrigation set	A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38032248487148	GS1	shelf box	25	In Commercial Distribution
Primary	08032248487147	GS1
Package	58032248487142	GS1	shipping carton	2	In Commercial Distribution
Previous	E261UDA582450	HIBCC

Device Sizes

Type	Value	Unit	Text
Outer Diameter	8	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius