FDA.reportPublic FDA data

BREG

Primary DI
00672736022177
Brand
BREG
Company
BREG, INC.
Model
TOPSHELF WRAP SHDLR L/XL
Catalog number
20.02655
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating
IMEPack, Hot Or Cold, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00672736022177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00672736022177006727360221776727360221770672736022177

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal therapy system pack, single-useA device intended to be applied to part of the body as part of a circulating-fluid thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003210607xx@xx.xx

Regulatory Flags#

DUNS number
604483321
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00672736142677BREGWRAPON PAD, HIP, WITH 29 IN STRAPS047602025-07-01
00672736022283BREGTOP SHELF KODIAK20.106012016-08-15
00672736022290BREGTOP SHELF KODIAK W/MU20.106022016-08-15
00672736022313BREGTOP SHELF KODIAK W/SHLDR20.106062016-08-15
00672736140987BREGPOLAR CARE WAVE INTL100716-0002024-11-19
00672736064818BREGVPULSE W/O PADSC000012016-08-15
00672736064825BREGVPULSE W SEQ COMP PADS (2)C000022016-08-15
70672736001416BREGPAD INTELLI FLO 3X5102052016-08-15
00672736000571BREGPC KODIAK COMBO IFP MU106022016-08-15
00672736000588BREGPC KODIAK COMBO IFP KNEE106042016-08-15
00672736000595BREGPC KODIAK COMBO IFP SHLDR XL106072016-08-15
00672736000601BREGPC KODIAK COMBO IFP MU LS106032016-08-15
00672736000618BREGPC KODIAK COMBO IFP SHLDR106062016-08-15
00672736000625BREGPOLAR CARE KODIAK106012016-08-15
00672736000632BREGPC KODIAK COMBO IFP ANKL106082016-08-15
00672736000649BREGPC KODIAK COMBO IFP KNEE CMP106052016-08-15
00672736000656BREGPC KODIAK COMBO IFP BACK106112016-08-15
00672736000663BREGPC KODIAK COMBO IFP ANKL CMP106092016-08-15
00672736000670BREGSTRAP IF PAD COMPRESSION106702016-08-15
00672736000687BREGIF KODIAK -Y- ADAPTER106992016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840295411637TherabodyTherabody, Inc.IME2026-06-01
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
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
00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040056Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040063Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00632615880106Bed BuddyDrive Devilbiss HealthcareIME2024-12-18
00632615880090Bed BuddyDrive Devilbiss HealthcareIME2024-11-21
00632615880083Bed BuddyDrive Devilbiss HealthcareIME2024-11-19
00057475281946BIOS LivingThermor LtdIME2024-08-19
00057475283001BIOS LivingThermor LtdIME2024-08-19
00057475282707BIOS LivingThermor LtdIME2024-03-21
00057475282714BIOS LivingThermor LtdIME2024-03-21
00057475282721BIOS LivingThermor LtdIME2024-03-21
10885632413797HalyardOWENS & MINOR DISTRIBUTION, INC.IME2024-03-11
10885632413896HalyardOWENS & MINOR DISTRIBUTION, INC.IME2024-03-04
10885632413902HalyardOWENS & MINOR DISTRIBUTION, INC.IME2024-03-04
10885632413919HalyardOWENS & MINOR DISTRIBUTION, INC.IME2024-03-04
00632615031003CAREXDrive Devilbiss HealthcareIME2024-01-31
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09