FDA.reportPublic FDA data

Carecube ISTARI

Primary DI
00860013374877
Brand
Carecube ISTARI
Company
Carecubes, Inc.
Model
1BX-930-00012
Catalog number
1BX-930-00012
Device description
Carecubes 1BX Manometer, Packaged
Published
2025-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGMChamber, Patient Isolation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGMChamber, Patient IsolationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231256000Carecube Negative Pressure Isolation ChamberCarecubes, Inc.2024-01-03LGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013374877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013374877008600133748778600133748770860013374877

GMDN Terms#

Term, Definition table
TermDefinition
Patient isolation tentA 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.

Contacts#

Phone, Email table
PhoneEmail
2027432273support@carecubes.com

Regulatory Flags#

DUNS number
117860649
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013374808Carecube ISTARI1BX-991-000361BX-991-000362025-11-07
00860013374815Carecube ISTARI1BX-610-001011BX-610-001012025-11-07
00860013374822Carecube ISTARI1BX-930-000081BX-930-000082025-11-07
00860013374839Carecube ISTARI1BX-930-000141BX-930-000142025-11-07
00860013374846Carecube ISTARI1B-991-000121B-991-000122025-11-07
00860013374853Carecube ISTARI1BX-930-000151BX-930-000152025-11-07
00860013374860Carecube ISTARI1B-991-000191B-991-000192025-11-07
00860013374884Carecube ISTARIM1-991-00030M1-991-000302025-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013374808Carecube ISTARICarecubes, Inc.LGM2025-11-07
00860013374815Carecube ISTARICarecubes, Inc.LGM2025-11-07
00860013374822Carecube ISTARICarecubes, Inc.LGM2025-11-07
00860013374839Carecube ISTARICarecubes, Inc.LGM2025-11-07
00860013374846Carecube ISTARICarecubes, Inc.LGM2025-11-07
00860013374853Carecube ISTARICarecubes, Inc.LGM2025-11-07
00860013374860Carecube ISTARICarecubes, Inc.LGM2025-11-07
00860013374884Carecube ISTARICarecubes, Inc.LGM2025-11-07