Airo®

Primary DI
00869346000200
Brand
Airo®
Company
MOBIUS IMAGING, LLC
Model
MobiCT-32
Catalog number
MobiCT-32
Device description
AIRO® Computed Tomography (CT) X-ray System
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10869346000207PackageGS11In Commercial Distribution
00869346000200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086934600020710869346000207
00869346000200008693460002008693460002000869346000200

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
800.253.3210INST.STRYKER.CS@STRYKER.COM

Regulatory Flags#

DUNS number
079149264
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29