Carecube ISTARI

Basic Information

• Brand Name: Carecube ISTARI
• Primary DI: 00860013374822
• Version / Model: 1BX-930-00008
• Catalog Number: 1BX-930-00008
• Company Name: Carecubes, Inc.
• Labeler DUNS: 117860649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-07
• Public Version: 1
• Public Version Date: 2025-11-17
• Public Version Status: New
• Public Device Record Key: b13f13b3-59c7-4e48-b03d-dd1491dac538

Device Description

1BX Packaged Canopy, within bag

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: Yes
• 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
LGM	Chamber, Patient Isolation	General Hospital	880.5450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63709	Patient isolation tent	A mobile device designed to be erected to provide environmental isolation of a contagious patient to protect hospital personnel and other patients from exposure to non-airborne infections (e.g., diphtheria, meningococcus) whilst the patient is being treated. It includes a collapsible frame with a canopy, designed to create a small room environment for healthcare personnel to enter, and it includes an electric air filtration mechanism; the air in the chamber is filtered before it is returned to the normal external atmosphere. It may include additional features (e.g., electric door mechanism). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013374822	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231256	000