FDA.reportPublic FDA data

Action®

Primary DI
00089904000231
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Disposable Cover
Catalog number
40102I
Device description
Action® Individual Overlay Cover
Published
2021-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00089904000231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904000231000899040002310899040002310089904000231

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Minimal UV exposure
Special Storage Condition, Specify00Store in clean, dry environment

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3017971414service@actionproducts.com

Regulatory Flags#

DUNS number
067543058
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00089904011404Action®OR Table Replacement Pad52140A2026-06-08
00089904002297Action®Mattress Overlay6400H2021-02-03
00089904002310Action®Mattress Overlay6405H2021-02-03
00089904002280Action®Mattress Overlay64002021-01-21
00089904002303Action®Mattress Overlay64052021-01-21
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
00089904000958Action®Arm Pad403122021-01-11
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
00089904000422Action®Disposable Cover401022021-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
16931918129815HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
10889483602911AirLife™AirLife Finland OyKME2025-04-17
10889483602928AirLife™AirLife Finland OyKME2025-04-17
10889483602935AirLife™AirLife Finland OyKME2025-04-17
10889483602942AirLife™AirLife Finland OyKME2025-04-17
10889483603031AirLife™AirLife Finland OyKME2025-04-17
10889483603048AirLife™AirLife Finland OyKME2025-04-17
10603354120669ComfortTopEHOB INCKME2025-01-22
M68959320040HAWK Advanced Hypothermia Management SetSafeguard US Operating, LLCKME2024-10-08