ROHO Dual Compartment Cushion

GUDID 00613732053345

Modified configuration of a ROHO Dual Compartment Cushion. It may be any size and include high, mid, or low profile cells.

Roho, Inc.

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• Primary Device ID: 00613732053345
• NIH Device Record Key: e86353bb-b228-41c3-b13d-74b3aa2017e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROHO Dual Compartment Cushion
• Version Model Number: 2RMODIFIED
• Company DUNS: 006614792
• Company Name: Roho, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613732053345 [Primary]

FDA Product Code

• KIC: Cushion, Flotation

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: 2022-12-05
• Device Publish Date: 2022-11-25

Devices Manufactured by Roho, Inc.

• 00613732053345 - ROHO Dual Compartment Cushion: 2022-12-05Modified configuration of a ROHO Dual Compartment Cushion. It may be any size and include high, mid, or low profile cells.
• 00613732053345 - ROHO Dual Compartment Cushion: 2022-12-05 Modified configuration of a ROHO Dual Compartment Cushion. It may be any size and include high, mid, or low profile cells.
• 00613732053352 - ROHO Single Compartment Cushion: 2022-12-05 Modified configuration of a ROHO Single Compartment Cushion. It may be any size and include high, mid, or low profile cells.
• 00613732079932 - ROHO Single Compartment Cushion: 2022-12-05 Small size configuration of a ROHO Single Compartment cushion. It may include high, mid, or low profile cells.
• 00613732079949 - ROHO Single Compartment Cushion: 2022-12-05 Large size configuration of a ROHO Single Compartment cushion. It may include high, mid, or low profile cells.
• 00613732084745 - ROHO QUADTRO SELECT HIGH PROFILE Cushion: 2022-12-05
• 00613732084752 - ROHO QUADTRO SELECT HIGH PROFILE Cushion: 2022-12-05
• 00613732084769 - ROHO QUADTRO SELECT HIGH PROFILE Cushion: 2022-12-05
• 00613732084776 - ROHO QUADTRO SELECT HIGH PROFILE Cushion: 2022-12-05