FDA.reportPublic FDA data

Inspired by Drive

Primary DI
00822383001463
Brand
Inspired by Drive
Company
Drive Devilbiss Healthcare
Model
WCF-1000-2GJB
Device description
Flexi Air Mesh Seat, 1, Jet Figther Blue
Published
2020-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00822383001463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822383001463008223830014638223830014630822383001463

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true
No natural rubber latex
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
20888277668000MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
10888277668003MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
04260764840557MedibinoNEO ring – TG PUR Gel - Size L - PU 6Kluba Medical GmbHPRN2024-09-06
04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHPRN2024-09-06
04260764840649MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50Kluba Medical GmbHPRN2024-09-06
04260764840656MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840663MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840670MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840687MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840694MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840564MedibinoNEO ring – TG PUR Gel - Size M - PU6Kluba Medical GmbHPRN2024-09-06
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
10810087350861CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351110CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351165CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351196CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351240CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351349CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351356CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351363CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351370CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351677CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351684CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351691CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351707CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351714CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351721CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351899CoulmedCoulmed Products Group LLCPRN2023-01-06