SunWrap Mini 12 Arm Wrap Extra Large SWMAXL

GUDID 00856525007488

SunWrap™ Compression System provides localized compression and visualization through a central transparent bladder covering the dressed site. SunWrap™ Compression systems provides localized compression and visualization to manage access site bleeding post-hemodialysis or any covered wound that would require compression to control bleeding.

SUN SCIENTIFIC, INC.

Compression/pressure tubular garment

• Primary Device ID: 00856525007488
• NIH Device Record Key: fa13cdae-f5c6-466a-9ccb-87d89cb7fd14
• Commercial Distribution Discontinuation: 2030-02-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunWrap Mini 12 Arm Wrap Extra Large
• Version Model Number: AW4050
• Catalog Number: SWMAXL
• Company DUNS: 609397224
• Company Name: SUN SCIENTIFIC, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com
• Phone: 914.479-5108
• Email: aalward@sun-scientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856525007488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070457

FDA Product Code

• MHW: Dressing, Compression

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: 2022-05-09
• Device Publish Date: 2022-04-29

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