Positioning Wedge 30-231-00

GUDID 10810044961086

Positioning Wedge 24" X 24" X 10.5"

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use

• Primary Device ID: 10810044961086
• NIH Device Record Key: 07c068ea-fcba-4ebb-8ff3-72289ec8eb94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positioning Wedge
• Version Model Number: 30-231-00
• Catalog Number: 30-231-00
• Company DUNS: 964459106
• Company Name: GENEVA HEALTHCARE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com
• Phone: 1-262-767-9870
• Email: info@genevahc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810044961089 [Primary]
GS1	10810044961086 [Package]; Contains: 00810044961089; Package: Case [2 Units]; In Commercial Distribution

FDA Product Code

• CCX: Support, Patient Position

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-28
• Device Publish Date: 2020-07-20

Devices Manufactured by GENEVA HEALTHCARE, LLC

• 00810044961638 - Anesthesia Head Rest: 2021-06-25 Anesthesia Head Rest 8.5" x 8.375" > 3" x 4.5"
• 00810044961614 - Disposable Medical Mat: 2021-05-13 Disposable Medical Mat, Columbia Blue - 18" x 30"
• 10810044961628 - Disposable Stool Medical Mat: 2021-05-13 Disposable Stool Medical Mat, Columbia Blue - 13" x 17"
• 00810044961317 - Elbow & Heel Protector: 2020-08-06 Pediatric Ulnar Nerve 7" x 4"
• 00810044961379 - Packaging Products: 2020-08-06 Pick & Shape Perforated Foam - Medium Square - 4" (1" x 1" Pick Square Size)
• 00810044961423 - Covered Cushions and Wedges: 2020-08-06 Convolute Top 10" Bed Wedge 10" x 24" x 24"
• 00810044961416 - Covered Cushions and Wedges: 2020-08-06 14" Molded Ring Cushion 2.25"x13"x15"
• 00810044961454 - Covered Cushions and Wedges: 2020-08-06 16" Molded Ring Cushion 2.75"x13.25"x16.5"