FDA.report

Action®

Primary DI
00089904006974
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Seating System Cover
Catalog number
CODX2020
Device description
Xact® Dartex® Cover
Published
2021-02-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KNNComponents, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00089904006974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904006974000899040069740899040069740089904006974

GMDN Terms

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.

Contacts

PhoneEmail
301.797.1414service@actionproducts.com

Regulatory Flags

DUNS number
067543058
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00089904004109Action®Seating SystemX12122021-02-09
00089904004130Action®Seating SystemX1214R2021-02-09
00089904004208Action®Seating SystemX1416R2021-02-09
00089904004215Action®Seating SystemX1416S2021-02-09
00089904004253Action®Seating SystemX1616R2021-02-09
00089904004277Action®Seating SystemX1618R2021-02-09
00089904004345Action®Seating SystemX18182021-02-09
00089904004413Action®Seating SystemX2018R2021-02-09
00089904004550Action®Seating SystemXS18202021-02-09
00089904004567Action®Seating SystemXS20162021-02-09
00089904004710Action®Seating SystemXL20182021-02-09
00089904004727Action®Seating SystemXSM16182021-02-09
00089904004734Action®Seating SystemXSM16162021-02-09
00089904004772Action®Seating SystemX2018D2021-02-09
00089904004840Action®Seating SystemXS2020R2021-02-09
00089904005014Action®Seating SystemXS1818R2021-02-09
00089904006646Action®Seating SystemX1414R2021-02-09
00089904006691Action®Seating SystemX1614R2021-02-09
00089904006714Action®Seating SystemX1616D2021-02-09
00089904006837Action®Seating SystemX2018S2021-02-09

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00815067013548ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013555ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013562ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013579ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
04714379299328MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299335MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299342MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299359MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
10197344158393MEDLINEMEDLINE INDUSTRIES, INC.KNN2025-07-28
00815067013074ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-07-21
00815067013081ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-07-21
10197344155279MEDLINEMEDLINE INDUSTRIES, INC.KNN2025-06-27
05407008321130mo-Vismo-VisKNN2025-03-27
05407008321147mo-Vismo-VisKNN2025-03-27
05407008321154mo-Vismo-VisKNN2025-03-27
05407008321161mo-Vismo-VisKNN2025-03-27
05407008321178mo-Vismo-VisKNN2025-03-27
05407008321185mo-Vismo-VisKNN2025-03-27
05407008321116mo-vismo-VisKNN2025-03-21
05407008321192mo-Vismo-VisKNN2025-03-21
05407008321208mo-vismo-VisKNN2025-03-21
05407008321215mo-vismo-VisKNN2025-03-21
09420051706217Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051706798Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709881Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709911Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709935Spex LimitedSPEX LIMITEDKNN2025-03-18