Prone Positioning Pillow 30-146-I

GUDID 10810044961055

P3 Infant 3-1/8" x 6-1/2" X 7-1/2"

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: 10810044961055
• NIH Device Record Key: a1c94726-4eae-4339-90cf-c84d272dbc1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prone Positioning Pillow
• Version Model Number: 30-146-I
• Catalog Number: 30-146-I
• 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	00810044961058 [Primary]
GS1	10810044961055 [Package]; Contains: 00810044961058; Package: Case [9 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

On-Brand Devices [Prone Positioning Pillow]

• 10810044961062: P3 Pediatric 3-5/8" X 8" X 9-1/4"
• 10810044961055: P3 Infant 3-1/8" x 6-1/2" X 7-1/2"
• 10810044961048: P3 Adult 5" X 10-1/4" X 12"