FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KMEBedding, Disposable, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00089904000231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904000231000899040002310899040002310089904000231

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Minimal UV exposure
Special Storage Condition, Specify00Store in clean, dry environment

Sterilization Methods

Method

Contacts

PhoneEmail
3017971414service@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
false
Sterilization required before use
false

Other Devices From This Company

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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

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