FDA.reportPublic FDA data

NA

Primary DI
00810050245531
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
9126
Device description
"Aquilion ONE INSIGHT Kit. Includes: 9006 - STRAP, CHIN (00810050242103), 9007 - STRAP, FOREHEAD W/ADULT PAD (00810050242134), 9008 - KIT, ADULT HEAD REST (00810050243209), 9009 - WEDGE, TILT (00810050242431), 9017 - WEDGE, KNEE, 10.7” x 21.88” x 18.33” (00810050242424), 9020F - PAD, PEDIATRIC POSITIONING (00810050241441), 9025 - HOLDER, CORONAL HEAD (00810050241229), 9061 – STRAP, WIDE SECURITY, 14.17” x 21.12” (20810050242909), 9062 - STRAP, NARROW SECURITY FOR THE SHIELD (20810050242886), 9077 - PAD, ROLLED EDGE FOOT EXTENSION (00810050241458), 9080 - SLIDE RAIL, DETACHABLE, AQULION ONE (10810050242841), 9112 - COVER, PROTECTIVE, FOOT EXTENSION PAD (10810050242674), 9113 - STRAP, WIDE BARIATRIC EXTENDER 30"" (00810050242172), 9114 - STRAP, NARROW BARIATRIC EXTENDER 30"" (00810050242158), 9121 – TABLE PAD COVER (00861001002659), 9125 – THE SHIELD, AQUILION ONE (00810050245524)"
Published
2024-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
FMQRestraint, Protective
IWYHolder, Head, Radiographic
KXJTable, Radiologic
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
FMQRestraint, ProtectiveGeneral Hospital1
IWYHolder, Head, RadiographicRadiology1
KXJTable, RadiologicRadiology2
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810050245531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050245531008100502455318100502455310810050245531

GMDN Terms#

Term, Definition table
TermDefinition
Multifunction body cushionA soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081253414
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050241618NAVMR33PUBB2020-09-24
00810050243483NA90192020-09-24
00810050241120NAVMR38X012020-09-24
00810050242462NA9012-A2020-09-24
00810050242479N/A9012-B2020-09-24
00810050242486NA9012-C2020-09-24
00810050242493N/A9012-D2020-09-24
00810050242509NA9013-A2020-09-24
00810050242516N/A9013-B2020-09-24
00810050242523NA9013-C2020-09-24
00810050242530N/A9013-D2020-09-24
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
00810050245548NA60012024-12-31
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31
00810050245449NA60002023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCCCX2024-08-12
G242PADCS1BLU9Techno-AideTechno-Aide, Inc.CCX2023-10-20
G242CPADPPC9Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242CPADPPF9Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242CPADPPM9Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242CPADPRC9Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242CPADPRF9Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242CPADPRM9Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242FIL129Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242FLB529Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242FLB589Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242FLB619Techno-AideTechno-Aide, Inc.CCX2023-02-13
G242FLB719Techno-AideTechno-Aide, Inc.CCX2023-02-13