FDA.report

Action®

Primary DI
00089904001665
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Disposable Cover
Catalog number
40801
Device description
Disposable Pad Protector
Published
2021-01-11
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
00089904001665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904001665000899040016650899040016650089904001665

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
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
false
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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