FDA.report

BREG

Primary DI
00672736000618
Brand
BREG
Company
BREG, INC.
Model
PC KODIAK COMBO IFP SHLDR
Catalog number
10606
Device description
1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10220 I-Flo Shoulder Pad
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
40672736000722PackageGS16In Commercial Distribution
00672736000618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4067273600072240672736000722
00672736000618006727360006186727360006180672736000618

GMDN Terms

TermDefinition
Circulating-fluid thermal therapy system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It includes a fluid pump and either a heater, or a means for cold therapy (e.g., refrigeration unit, permitting addition of independently cooled ice water) or both; it does not include an air pump for wrap inflation. It is intended for use in both professional and home settings.

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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