Anti-Rotational Wedge for PRIMOBoot ARW01

GUDID 10810006680000

Anti-Rotational Wedge for PRIMOBoot, Black

PRIMO INC

Heel protector

• Primary Device ID: 10810006680000
• NIH Device Record Key: 4655da5e-69d7-4625-a834-17f36982b9be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Rotational Wedge for PRIMOBoot
• Version Model Number: ARW01
• Catalog Number: ARW01
• Company DUNS: 958758146
• Company Name: PRIMO 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: true
• Lot Batch: true
• Serial Number: false
• 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	00810006680003 [Primary]
GS1	10810006680000 [Package]; Contains: 00810006680003; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• FMP: Protector, Skin Pressure

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: 2019-03-11
• Device Publish Date: 2019-02-20

Devices Manufactured by PRIMO INC

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• 10810006683537 - AirFloat Static Air Seat Cushion: 2021-08-03 AirFloat Static Air Seat Cushion (17"x17") with pump
• 10810006683742 - Wipe Down Body Wedge Set: 2021-08-03 Wipe Down Body Wedge Set (1 each-BPW04F/ 1 each-BPW04FL) - 12/ST/CA
• 10810006683759 - Wipe Down Body Wedge Set: 2021-08-03 Wipe Down Body Wedge Set (2 each - BPW04F) 12 ST/CA
• 10810006683780 - Glide & Guide Turn System Kit: 2021-08-03 GGTS02 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10F; 12 Kit/Case
• 10810006683797 - Glide & Guide Turn System Kit: 2021-08-03 GGTS02B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW10F; 12 Kit/Case
• 10810006683803 - Glide & Guide Turn System Kit: 2021-08-03 GGTS01 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW10R; 10 Kit/Case