FDA.reportPublic FDA data

NA

Primary DI
00810050242646
Brand
NA
Company
DOMICO MED-DEVICE, LLC
Model
9002
Device description
COVER, PROTECTIVE, 31.00 X 86.00
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KXJTable, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050242643PrimaryGS10
00810050242646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005024264310810050242643
00810050242646008100502426468100502426460810050242646

GMDN Terms#

Term, Definition table
TermDefinition
Medical cushion coverA device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length86Inch
Width31Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081253414
Device count
4
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050245579NA278092025-12-09
00810050245562NA335572025-09-24
10810050245545NA60012024-12-31
10810050245552NA60022024-12-31
00810050245524NA91252024-06-21
00810050245531NA91262024-06-21
00810050245517NA333722023-12-29
00810050245500NA4-UF2023-10-31
10810050245446NA60002023-10-13
00810050245494NA2822023-10-13
00810050245470NA169-202023-05-01
00810050245487NA2-UF2023-05-01
00810050240840NA1592020-06-11
00810050243148NA128-UF2020-08-12
00810050245289NA1632022-05-27
00810050245302NA142-202022-05-27
00810050245456NA303-UF2022-11-18
00810050245432NA209-202022-11-10
00810050245401NA333502022-10-31
00810050245425NA108-82022-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050245579NADOMICO MED-DEVICE, LLCKXJ2025-12-09
04046768146037Carbon Fiber Table TopMAQUET GmbHKXJ2025-01-27
04046768146044Carbon Fiber Table TopMAQUET GmbHKXJ2025-01-27
04046768146051Carbon Fiber Table TopMAQUET GmbHKXJ2025-01-27
00887761975682Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00887761975699Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2025-01-20
00857534006721Headboard AssemblyDEERFIELD IMAGING, INC.KXJ2024-10-04
00810050245524NADOMICO MED-DEVICE, LLCKXJ2024-06-21
00810050245531NADOMICO MED-DEVICE, LLCKXJ2024-06-21
00858340006448Del Medical/UniversalDel Medical, Inc.KXJ2024-03-18
00858340006455Del Medical/UniversalDel Medical, Inc.KXJ2024-03-18
00858340006462Del Medical/UniversalDel Medical, Inc.KXJ2024-03-18
05999116126108Z-TABLECONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságKXJ2023-12-04
00810050245500NADOMICO MED-DEVICE, LLCKXJ2023-10-31
00195278629234NAGE Medical Systems (Tianjin) Co., Ltd.KXJ2023-08-04
60889976554104CARESTREAM DR Long Length Imaging StandCARESTREAM HEALTH, INC.KXJ2023-06-26
00810050245470NADOMICO MED-DEVICE, LLCKXJ2023-05-01
10841962119389Insight™QfixKXJ2023-01-24
10841962119396Insight™QfixKXJ2023-01-24
00887761967342Orthopedic ExtensionBaxter Medical Systems GmbH + Co. KGKXJ2023-01-17
00887761973893Control UnitsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-17
00887761971608Side Rail Adapter & ExtensionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-11
00887761974593TS 7500Baxter Medical Systems GmbH + Co. KGKXJ2023-01-11
00887761968325iLED7 Surgical LightBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761972841Head-Positioning accessoriesBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761973343Arm-PositioningBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761973350Arm-PositioningBaxter Medical Systems GmbH + Co. KGKXJ2023-01-05
00887761967625X-Ray-Cassette-HandlingBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967748Leg SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03
00887761967793Head SectionsBaxter Medical Systems GmbH + Co. KGKXJ2023-01-03