FDA.reportPublic FDA data

RACK+,5562,5505(2),5581,5531 & 5539(6PC)

Primary DI
00840314806314
Brand
RACK+,5562,5505(2),5581,5531 & 5539(6PC)
Company
Hausmann Enterprises, LLC
Model
5562-100
Published
2022-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IODComponents, Exercise

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314806314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314806314008403148063148403148063140840314806314

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose caseworkFurniture consisting of different units, e.g., cabinets, shelves, racks, worktops, combined and installed in a healthcare facility to provide users with a general-purpose functional work and storage place. This will also separate the floor/room area creating a practical discrete working environment for the staff. The units are used to store materials, supplies, devices, records, samples, and other items. This furniture is usually modular and constructed using thicker panels and more long-lasting surface finishes than ordinary office/domestic furniture.

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
00840314812339"B-COOL KNEE IMMOB 20"" W/POCKETS"HM26422025-01-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840314816108"STAIRS,TIMBER,MINI STRAIGHT,2 6""STEPS,3"Hausmann Enterprises, LLCIOD2025-04-14
00840314816122"STAIRS,TIMBER,SINGLE-SIDE,4 6""STEPS"Hausmann Enterprises, LLCIOD2025-04-14
00810113576367ViveVIVE HEALTH LLCIOD2024-08-20
10810113576364ViveVIVE HEALTH LLCIOD2024-08-20
00810113574356ViveVIVE HEALTH LLCIOD2024-07-17
00810113577296ViveVIVE HEALTH LLCIOD2024-07-17
10810113574353ViveVIVE HEALTH LLCIOD2024-07-17
10810113577293ViveVIVE HEALTH LLCIOD2024-07-17
00057475571184BIOS LivingThermor LtdIOD2023-09-18
10057475571181BIOS LivingThermor LtdIOD2023-09-18
00810113573403ViveVIVE HEALTH LLCIOD2023-08-23
10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
00818323029529ViveVIVE HEALTH LLCIOD2023-08-02
00818323029536ViveVIVE HEALTH LLCIOD2023-08-02
10818323029526ViveVIVE HEALTH LLCIOD2023-08-02
10818323029533ViveVIVE HEALTH LLCIOD2023-08-02
G505MRBHS0Balance Harness M.A.S.S. Rehab, LLCIOD2023-08-01
G505MRHSH0Healing Solutions HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHB0Unloading Harness BariatricM.A.S.S. Rehab, LLCIOD2023-08-01
G505MRUHS0Unloading HarnessM.A.S.S. Rehab, LLCIOD2023-08-01
00840252911828Dig-o-meterTherafin CorporationIOD2023-07-06
00810041982353VIVEVIVE HEALTH LLCIOD2023-06-30
10810041982350VIVEVIVE HEALTH LLCIOD2023-06-30
07290019733003HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733836TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
07290019733843TutorCart WorkStationMEDITOUCH LTDIOD2023-06-21
072900197338503DTutor StationMEDITOUCH LTDIOD2023-06-21
072900197338673DTutorMEDITOUCH LTDIOD2023-06-21
07290019733874LegTutorMEDITOUCH LTDIOD2023-06-21
07290019733881LegTutorMEDITOUCH LTDIOD2023-06-21