FDA.reportPublic FDA data

Disposable Stool Medical Mat

Primary DI
10810044961628
Brand
Disposable Stool Medical Mat
Company
GENEVA HEALTHCARE, LLC
Model
GHC-1317-10DMB
Catalog number
GHC-1317-10DMB
Device description
Disposable Stool Medical Mat, Columbia Blue - 13" x 17"
Published
2021-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10810044961628PackageGS110In Commercial Distribution
00810044961621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004496162810810044961628
00810044961621008100449616218100449616210810044961621

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
964459106
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

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
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
00810044961485Covered Cushions and Wedges60-300-00 60-300-00 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