POWER PLAY

GUDID 04042809585926

PP ELBOW WRAP

Compression Solutions, LLC

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 04042809585926
• NIH Device Record Key: 4898f61a-9f70-4857-9a98-b2efd9dc3b09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWER PLAY
• Version Model Number: PPEL22
• Company DUNS: 879909877
• Company Name: Compression Solutions, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM
• Phone: +1(800)537-1063
• Email: BSN.ORDERS@BSNMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04042809585926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122154

FDA Product Code

• IRP: MASSAGER, POWERED INFLATABLE TUBE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-02
• Device Publish Date: 2017-04-04

On-Brand Devices [POWER PLAY]

• 04042809586022: HIP WRAP
• 04042809585926: PP ELBOW WRAP
• 04042809585896: CALF MASSAGE WRAPS
• 04042809585889: POWERPLAY ANKLE WRAP
• 04042809585773: POWERPLAY PUMP
• 04042809585766: POWERPLAY WRIST - LEFT
• 04042809585759: POWERPLAY WRIST - UNIVERSAL
• 04042809585742: SHOULDER WRAP
• 04042809585711: POWERPLAY 360 KNEE
• 04042809585704: POWERPLAY FULL LEG
• 04042809585698: KNEE WRAP