FDA.report

Action®

Primary DI
00089904010070
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Seating System Cover
Catalog number
COABXP2016
Device description
Xact® LP 20x16 Cover
Published
2021-02-03
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

Related Records

Contact Domains

Product Codes

CodeName
KNNComponents, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00089904010070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904010070000899040100700899040100700089904010070

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.

Sterilization Methods

Method

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
00089904011374Action®OR Table Replacement Pad70915A2026-01-08
00089904011381Action®OR Table Replacement Pad779102026-01-08
00089904011398Action®OR Table Replacement Pad55915C2026-01-08
00089904011367Action®OR Table Replacement Pad75910D2025-11-18
00089904011350Action®OR Table Replacement Pad57140C2025-08-28
00089904011343Action®OR Table Replacement Pad721402025-01-06
00089904011336Action®OR Table Replacement Pad57310C2024-09-10
00089904009531Action®Disposable Cover40616DC2021-01-14
00089904009548Action®Disposable Cover40617DC2021-01-14
00089904009555Action®Disposable Cover40618DC2021-01-14
00089904009562Action®Disposable Cover40619DC2021-01-14
00089904009579Action®Disposable Cover40620DC2021-01-14
00089904009586Action®Disposable Cover40621DC2021-01-14
00089904011329Action®OR Table Replacement Pad57310B2024-05-28
00089904010292Action®OR Table Replacement Pad51916A2024-04-22
00089904010230Action®OR Table Replacement Pad57350B2023-10-17
00089904011312Action®Wheelchair Cushion9000-2CS2023-08-03
00089904011305Action®OR Table Replacement Pad51939C2023-07-12
00089904011299Action®OR Table Replacement Pad559152023-06-19
00089904011282Action®OR Table Replacement Pad51944C2023-06-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09420082699434Spex SeatingSPEX LIMITEDKNN2026-02-20
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05407008321246mo-vismo-VisKNN2026-01-01
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