FDA.reportPublic FDA data

Positioning Rolls and Bolsters

Primary DI
10810044960331
Brand
Positioning Rolls and Bolsters
Company
GENEVA HEALTHCARE, LLC
Model
30-215-00
Catalog number
30-215-00
Device description
"Small Bolster 18"" X 7"""
Published
2020-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810044960334PackageGS16In Commercial Distribution
10810044960331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044960334008100449603348100449603340810044960334
1081004496033110810044960331

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA 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 single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-262-767-9870info@genevahc.com

Regulatory Flags#

DUNS number
964459106
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810044961645Anesthesia Head Rest W-TSF-1002W-TSF-10022021-06-17
00810044961638Anesthesia Head Rest W-TSF-1002W-TSF-10022021-06-17
00810044961621Disposable Stool Medical MatGHC-1317-10DMBGHC-1317-10DMB2021-05-05
00810044961614Disposable Medical MatGHC-1830-5DMBGHC-1830-5DMB2021-05-05
10810044961628Disposable Stool Medical MatGHC-1317-10DMBGHC-1317-10DMB2021-05-05
10810044961390Packaging ProductsPSPF-CM12122PSPF-CM121222020-07-29
10810044961406Packaging ProductsPSPF-CS12122PSPF-CS121222020-07-29
10810044961475Covered Cushions and Wedges60-201-00 60-201-00 2020-07-29
10810044961598Heel & Toe Protector 130413042020-07-29
00810044961324Elbow & Heel Protector 30-111-P30-111-P2020-07-29
00810044961430Covered Cushions and Wedges60-124-CT 60-124-CT 2020-07-29
00810044961447Covered Cushions and Wedges60-100-0060-100-002020-07-29
00810044961461Covered Cushions and Wedges60-200-00 60-200-00 2020-07-29
00810044961492Covered Cushions and Wedges60-300-00 60-300-00 2020-07-29
00810044961515Covered Cushions and Wedges60-602-00 60-602-00 2020-07-29
00810044961317Elbow & Heel Protector 30-111-P30-111-P2020-07-29
00810044961379Packaging ProductsPSPF-M12124PSPF-M121242020-07-29
00810044961423Covered Cushions and Wedges60-124-CT 60-124-CT 2020-07-29
00810044961416Covered Cushions and Wedges60-100-0060-100-002020-07-29
00810044961454Covered Cushions and Wedges60-200-00 60-200-00 2020-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811836030907TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00811836030921TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
20811836030215TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05