FDA.reportPublic FDA data

"B-COOL KNEE IMMOB 20"" W/POCKETS"

Primary DI
00840314812339
Brand
"B-COOL KNEE IMMOB 20"" W/POCKETS"
Company
Hausmann Enterprises, LLC
Model
HM2642
Device description
"B-COOL KNEE IMMOB 20"" W/POCKETS SKU HM2642"
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ITQJoint, Knee, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314812339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314812339008403148123398403148123390840314812339

GMDN Terms#

Term, Definition table
TermDefinition
Knee support/thermal therapy bandageA non-sterile fabric material formed to fit around the knee and intended to provide pressure to support the joint following injury (e.g., sports injuries), disease (e.g., rheumatism), and/or surgery; it is designed to accommodate the insertion of a hot/cold pack(s) to provide heat or cold therapy for the skin and underlying tissues to facilitate the reduction of oedema and pain. The device typically includes fasteners; it may be used in a healthcare facility or at home. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001892660
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314812667B-COOL COLD THERAPY WRAP UNIVHM33302025-01-01
00840314812728"B-COOL CRYO WRAP 24"" W/2,2.0 PKS"HM33972025-01-01
00840314816023B-COOL KNEE WRAP W/2, 2.0 PKSHM33822025-01-01
00840314816108"STAIRS,TIMBER,MINI STRAIGHT,2 6""STEPS,3"15262025-04-14
00840314816122"STAIRS,TIMBER,SINGLE-SIDE,4 6""STEPS"15272025-04-14
00840314811134SPORT-TRAC KNEE STRAP LGHM01242025-01-31
00840314811417ANKLIZER PUMP AIR WALKER LGHM03342025-01-31
00840314815118TGA-TENNIS ELBOW GEL/AIR REGHM74252025-01-31
00840314815125TGA-TENNIS ELBOW GEL/AIR XLONGHM74262025-01-31
00840314812285F8X LACER ANKLE W/STAYS SMHM25322025-01-02
00840314812308F8X LACER ANKLE W/STAYS LGHM25342025-01-02
00840314811097UNIV ARM SLING W/FOAM STRAP ADULTHM00192025-01-01
00840314811165ELASTIC ANKLE SUPPORT SMHM01302025-01-01
00840314811172ELASTIC ANKLE SUPPORT MDHM01312025-01-01
00840314811189ELASTIC ANKLE SUPPORT LGHM01322025-01-01
00840314811196ELASTIC ANKLE SUPPORT XLHM01332025-01-01
00840314811202ELASTIC ELBOW SUPPORT SMHM01342025-01-01
00840314811219ELASTIC ELBOW SUPPORT MDHM01352025-01-01
00840314811226ELASTIC ELBOW SUPPORT MDHM01362025-01-01
00840314811233ELASTIC ELBOW SUPPORT XLHM01372025-01-01

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Primary DI, Brand, Company table
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0060927120038820'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOBDARCO INTERNATIONAL, INC.ITQ2023-02-08