FDA.reportPublic FDA data

Jenx

Primary DI
05056235202813
Brand
Jenx
Company
JENX LIMITED
Model
COV02060
Device description
Cover For Medium Back Pad Pink
Published
2023-10-06
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
INNChair, Adjustable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056235202813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056235202813050562352028135056235202813

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
291659639
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056235223184Jenx (Daytot)207-6012025-08-08
05056235223191Jenx (Daytot)207-6022025-08-08
05056235223207Jenx (Daytot)207-6002025-08-08
05056235223214Jenx (Daytot)207-6042025-08-08
05056235223221Jenx (Daytot)207-6052025-08-08
05056235223276Jenx (Daytot)207-6062025-08-08
05056235223283Jenx (Daytot)207-6112025-08-08
05056235223290Jenx (Daytot)207-6122025-08-08
05056235223306Jenx (Daytot)207-6132025-08-08
05056235223313Jenx (Daytot)207-6142025-08-08
05056235223320Jenx (Daytot)207-6152025-08-08
05056235223337Jenx (Daytot)208-6002025-08-08
05056235223344Jenx (Daytot)208-6012025-08-08
05056235223351Jenx (Daytot)208-6022025-08-08
05056235223405Jenx (Daytot)208-6132025-08-08
05056235203858Jenx COVH12024-05-10
05056235203865Jenx COVH22024-05-10
05056235203872Jenx COVH32024-05-10
05056235203889Jenx COVH4-012024-05-10
05056235203896Jenx COVH4-022024-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04034089107745Swifty 3 Reha-Buggy (LB)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftINN2026-05-26
00840456218709JMUJMU DENTAL, INCINN2026-03-09
00840456218716JMUJMU DENTAL, INCINN2026-03-09
00840456218723JMUJMU DENTAL, INCINN2026-03-09
00840456218730JMUJMU DENTAL, INCINN2026-03-09
00840456218747JMUJMU DENTAL, INCINN2026-03-09
00840456218754JMUJMU DENTAL, INCINN2026-03-09
00840456218761JMUJMU DENTAL, INCINN2026-03-09
00840456218778JMUJMU DENTAL, INCINN2026-03-09
06975960550589noneZhejiang Mateside Medical Devices Technology Co., LtdINN2026-01-15
10858921006222ActiveAidALTIMATE MEDICAL INC.INN2026-01-05
00628758004448RazRaz Design IncINN2025-05-28
00062875800444RazRaz Design IncINN2025-03-11
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
10858921006215ActiveAidALTIMATE MEDICAL INC.INN2025-01-09
00628758009009ZwimRaz Design IncINN2024-11-06
00850010988702Mor-Medical New EraMoroles Investments, LLCINN2024-07-16
10197344018840MEDLINEMEDLINE INDUSTRIES, INC.INN2024-06-26
00628758001027JazRaz Design IncINN2024-06-12
00628758002024JazRaz Design IncINN2024-06-12
05056235203858Jenx JENX LIMITEDINN2024-05-10
05056235203865Jenx JENX LIMITEDINN2024-05-10
05056235203872Jenx JENX LIMITEDINN2024-05-10
05056235203889Jenx JENX LIMITEDINN2024-05-10
05056235203896Jenx JENX LIMITEDINN2024-05-10
05056235203902Jenx JENX LIMITEDINN2024-05-10
05056235203919Jenx JENX LIMITEDINN2024-05-10