FDA.reportPublic FDA data

INSPIRED

Primary DI
00822383937984
Brand
INSPIRED
Company
Drive Devilbiss Healthcare
Model
PCH-340M
Device description
InspiredSeating & Positionin Product Description: Contoured Harness, Neop, Rear Pull, M
Published
2019-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PRNPediatric position holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRNPediatric Position HolderGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822383937984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383937984008223839379848223839379840822383937984

GMDN Terms#

Term, Definition table
TermDefinition
Assistive automobile seatbelt/harnessA device used to modify a standard motor vehicle, e.g., a car or van, to adapt or replace the seatbelt functionality so that it can be used by a person with a disability. It will give the required degree of seatbelt safety and be adapted to suit the user of the vehicle providing a three-point or four-point seatbelt or belt vest ensuring his/her safety during travel.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277668003MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
04260764840823MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840830MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
10810087355965CoulmedCoulmed Products Group LLCPRN2023-02-07
00860008770608SmoltapSmoltap, Inc.PRN2022-10-27
10860008770612SmoltapSmoltap, Inc.PRN2022-10-27
00610570004812DANNY SLING 10-18 LBSBird & Cronin, LLCPRN2022-08-20
00610570004850DANNY SLING 2-5 LBSBird & Cronin, LLCPRN2022-08-20
00610570006755DANNY SLING 5-9 LBSBird & Cronin, LLCPRN2022-08-20
00610570007301KERRY KUDDLER 18-40 LBSBird & Cronin, LLCPRN2022-08-20
40193489036658MedlineMEDLINE INDUSTRIES, INC.PRN2021-10-08
00822383971704Inspired by DriveDrive Devilbiss HealthcarePRN2020-07-01
00822383971711Inspired by DriveDrive Devilbiss HealthcarePRN2020-07-01
00822383971728Inspired by DriveDrive Devilbiss HealthcarePRN2020-07-01
00822383971735Inspired by DriveDrive Devilbiss HealthcarePRN2020-07-01
00822383986739Inspired by DriveDrive Devilbiss HealthcarePRN2020-07-01
00822383986746Inspired by DriveDrive Devilbiss HealthcarePRN2020-07-01
00822383989518Inspired by DriveDrive Devilbiss HealthcarePRN2020-07-01
00822383001456Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383001463Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383001470Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383001487Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383001494Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383001500Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383001524Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383001920Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383002309Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383002316Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383002323Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20
00822383571003Inspired by DriveDrive Devilbiss HealthcarePRN2020-02-20