FDA.reportPublic FDA data

Sharper Image

Primary DI
00843479108552
Brand
Sharper Image
Company
Merchsource, LLC
Model
1012070,1012654, 1017191
Published
2024-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843479108552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843479108552008434791085528434791085520843479108552

GMDN Terms#

Term, Definition table
TermDefinition
Eye heat therapy pack, reusableA device intended to be placed over closed eyes to apply heat/steam for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is typically in the form of a mask-shaped fabric envelope which either: 1) contains a heat-retaining substance intended to be heated in a microwave oven prior to use; or 2) includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 8003742744isupport@merchsource.com

Regulatory Flags#

DUNS number
121820737
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840397513215Sharper Image10193412026-04-23
00840397513284Sharper Image10193482026-02-17
00840397501151Sharper Image10180182025-09-22
00840397503223Sharper Image10182392025-09-22
00840397517961Sharper Image10198522025-06-06
00843479127003Sharper Image10126542025-01-01
00843479157772Sharper Image10149632024-08-03
00843479107487Sharper Image10118522024-06-01
00843479107494Sharper Image10118532024-06-01
00843479107500Sharper Image10118542024-06-01
00843479124149Sharper Image10122872024-06-01
00843479126259Sharper Image10125492024-06-01
00843479137637Sharper Image10135392024-06-01
00843479157758Sharper Image10149612024-06-01
00843479159653Sharper Image10152432024-06-01
00843479166262Sharper Image1016761, 10153522024-06-01
00843479185256Sharper Image10173392024-06-01
00843479198263Sharper Image10107662024-06-01
00843479164954Sharper Image10098222024-04-17
00843479107418Sharper Image10118272024-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178885954Arctic FlexVIVE HEALTH LLCIME2026-05-06
00840397513215Sharper ImageMerchsource, LLCIME2026-04-23
307073870439893M™3M COMPANYIME2026-04-21
307073870439963M™3M COMPANYIME2026-04-21
10735282287845MunchkinMUNCHKIN, INC.IME2026-03-18
00197998026133Solventum™Solventum US LLCIME2026-02-15
00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.IME2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
00810113683638Cold Compression Wrap, Pro-Ankle WrapManamed, Inc.IME2025-09-26
00810113683645Cold Compression Wrap, Pro-Back WrapManamed, Inc.IME2025-09-26
00810113683652Cold Compression Wrap, Pro-Elbow WrapManamed, Inc.IME2025-09-26
00810113683669Cold Compression Wrap, Pro-Hip WrapManamed, Inc.IME2025-09-26
00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.IME2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
00850073571101American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00850073571118American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040056Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040063Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00810178880300Arctic FlexVIVE HEALTH LLCIME2025-04-04