FDA.reportPublic FDA data

Dr. Brown's

Primary DI
00072239321300
Brand
Dr. Brown's
Company
Dr. Brown's Company
Model
HG104
Device description
Gripebelt with teether
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reusable
MEFRing, Teething, Non-Fluid Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1
MEFRing, Teething, Non-Fluid FilledDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00072239321300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00072239321300000722393213000722393213000072239321300

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, reusableA non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-778-9001info@drbrownsbaby.com

Regulatory Flags#

DUNS number
055872634
Device count
1
DM exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00072239303597Dr. Brown'sSB42002-WEB2026-06-08
00072239303603Dr. Brown'sSB412-MED2026-06-08
00072239303863Dr. Brown'sSB82002-WEB2026-06-08
00072239306130Dr. Brown'sSB812-MED2026-06-08
00072239307274Dr. Brown'sSB05007-WEB2026-06-08
00072239310472Dr. Brown'sSB815-MED2026-06-08
00072239313060Dr. Brown'sSB417-MED2026-06-08
00072239325049Dr. Brown'sSB816-MED2026-06-08
00072239329252Dr. Brown'sAC2802026-06-08
00072239329269Dr. Brown'sAC2812026-06-08
00072239330265Dr. Brown'sWB51100-MED2026-06-08
00072239330272Dr. Brown'sWB91100-MED2026-06-08
00072239330753Dr. Brown'sTE4552026-06-08
00072239331842Dr. Brown'sTE1102026-06-08
00072239331859Dr. Brown'sTE2012026-06-08
00072239331866Dr. Brown'sTE1112026-06-08
00072239331873Dr. Brown'sTE2112026-06-08
00072239331897Dr. Brown'sTE1122026-06-08
00072239332139Dr. Brown'sTE4512026-06-08
00072239332146Dr. Brown'sTE4522026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696198189B.PUREFOURSTAR GROUP INC.MEF2026-06-09
00049696508339THERA PlusFOURSTAR GROUP INC.IME2026-06-09
00049696508346B.PUREFOURSTAR GROUP INC.IME2026-06-09
00049696712194B.PUREFOURSTAR GROUP INC.MEF2026-06-09
00049696898232B.PUREFOURSTAR GROUP INC.MEF2026-06-09
00050428299838CVSHealthFOURSTAR GROUP INC.IME2026-06-09
00072239329252Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239329269Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239330753Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331842Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331859Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331866Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331873Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239331897Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239332139Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239332146Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239333143Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239333402Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239333457Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334751Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334850Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334867Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239334874Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
00072239335000Dr. Brown'sDr. Brown's CompanyMEF2026-06-08
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00197998026133Solventum™Solventum US LLCIME2026-02-15