FDA.report

BREG

Primary DI
00672736001097
Brand
BREG
Company
BREG, INC.
Model
PAD BACK W/LONG STRPS WO
Catalog number
09805
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications

CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00672736001097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00672736001097006727360010976727360010970672736001097

GMDN Terms

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

Contacts

PhoneEmail
8003210607xx@xx.xx

Regulatory Flags

DUNS number
604483321
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
true
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
00672736142677BREGWRAPON PAD, HIP, WITH 29 IN STRAPS047602025-07-01
00672736140987BREGPOLAR CARE WAVE INTL100716-0002024-11-19
00672736141465BREGPINNACLE CERV 172 W/O REPL PADSSP60172-0002023-09-11
00672736141472BREGPINNACLE CERV TX 174 W/O REPL PADSSP60174-0002023-09-11
00672736141489BREGPINNACLE CERV MP 180 W/O REPL PADSSP60180-0002023-09-11
00672736141496BREGASCEND CERV 172, SHRT, W/O REPL PADSSP50172-0202023-09-11
00672736141502BREGASCEND CERV 172, REGULAR, W/O REPL PADSSP50172-0302023-09-11
00672736141519BREGASCEND CERV 172, TALL, W/O REPL PADSSP50172-0402023-09-11
00672736141526BREGASCEND CERV 172, X-TALL, W/O REPL PADSSP50172-0502023-09-11
00672736141533BREGASCEND PD1 PED COLLAR W/O REPL PADSSP50272-0102023-09-11
00672736141540BREGASCEND PD2 PED COLLAR W/O REPL PADSSP50272-0202023-09-11
00672736141557BREGASCEND PD3 PED COLLAR W/O REPL PADSSP50272-0302023-09-11
00672736141564BREGASCEND PD4 PED COLLAR W/O REPL PADSSP50272-0402023-09-11
00672736141571BREGASCEND PD5 PED COLLAR W/O REPL PADSSP50272-0502023-09-11
00672736026694BREGPC KODIAK INTL100291-0002023-06-22
00672736026700BREGIF PAD SHOULDER INTL100292-0002023-06-22
00672736026717BREGIF PAD SHOULDER XL INTL100293-0002023-06-22
00672736026724BREGIF PAD KNEE INTL100294-0002023-06-22
00672736026731BREGIF PAD KNEE COMP INTL100295-0002023-06-22
00672736026748BREGIF PAD MU INTL100296-0002023-06-22

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