FDA.report

POSITIONING PILLOW,CUBE,INCLINE,MED BLUE

Primary DI
00840314807014
Brand
POSITIONING PILLOW,CUBE,INCLINE,MED BLUE
Company
Hausmann Enterprises, LLC
Model
38
Published
2022-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IODComponents, Exercise

Product Code Classifications

CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840314807014PrimaryGS10

GMDN Terms

TermDefinition
Freestanding patient positioner, reusableA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001892660
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
false
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
00840314816108STAIRS,TIMBER,MINI STRAIGHT,2 6"STEPS,315262025-04-14
00840314816122STAIRS,TIMBER,SINGLE-SIDE,4 6"STEPS15272025-04-14
00840314811134SPORT-TRAC KNEE STRAP LGHM01242025-01-31
00840314811417ANKLIZER PUMP AIR WALKER LGHM03342025-01-31
00840314812339B-COOL KNEE IMMOB 20" W/POCKETSHM26422025-01-31
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
00840314811608SPRINT ANKLE STABILIZER SMHM06222025-01-01
00840314811615SPRINT ANKLE STABILZIER TRNR/SPORTHM06232025-01-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840314816108STAIRS,TIMBER,MINI STRAIGHT,2 6"STEPS,3Hausmann Enterprises, LLCIOD2025-04-14
00840314816122STAIRS,TIMBER,SINGLE-SIDE,4 6"STEPSHausmann Enterprises, LLCIOD2025-04-14
10810113576364ViveVIVE HEALTH LLCIOD2024-08-20
10810113574353ViveVIVE HEALTH LLCIOD2024-07-17
10810113577293ViveVIVE HEALTH LLCIOD2024-07-17
10057475571181BIOS LivingThermor LtdIOD2023-09-18
10810113573400ViveVIVE HEALTH LLCIOD2023-08-23
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
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
07290019733898ArmTutorMEDITOUCH LTDIOD2023-06-21
07290019733904ArmTutorMEDITOUCH LTDIOD2023-06-21
07290019733911HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733928HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733935HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733942HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733959HandTutorMEDITOUCH LTDIOD2023-06-21
07290019733966HandTutorMEDITOUCH LTDIOD2023-06-21