FDA.reportPublic FDA data

BREG

Primary DI
00672736065303
Brand
BREG
Company
BREG, INC.
Model
VPULSE THERM PAD ANKL
Catalog number
C00034
Published
2016-08-15
Public version status
Update
Distribution status
Not 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
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122640000VPULSECothera, LLC2013-02-22JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00672736065303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00672736065303006727360653036727360653030672736065303

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable hot/cold therapy pack/electric pumpA non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs with an air inflation sleeve, a mains electricity (AC-powered) air pump with controls, and air-conduction tubing; the pack(s) is heated/cooled independently of the system (e.g., cooled using chilling unit) and may be anatomically specific. The unit may be programmed for selected treatment plans. It is intended for use in both professional and home settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003210607xx@xx.xx

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00672736141649BREGDVT GUARDIANDVT0012026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
96973521878410BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878434BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878441BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878564BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878588BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878595BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878601BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878618BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
06976287180367Compression Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.JOW2026-07-10
00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18