FDA.report

Action®

Primary DI
00089904006493
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
Repair Patch
Catalog number
KIT003
Device description
3'x4" Repair Kit
Published
2021-01-21
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
00089904006493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904006493000899040064930899040064930089904006493

GMDN Terms

TermDefinition
Mattress repair patchA non-sterile device intended to repair a mattress or other suitable soft surface (e.g., bedrail pad) where there is a tear, cut, or puncture, to prevent further damage and help promote hygiene. It is a small non-latex patch with an adhesive on one side intended to cover and adhere to the damaged surface and produce a smooth wipe-clean surface. It is typically available in a variety of shapes/sizes. Once applied this device cannot be reused on another surface.

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

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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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