SunWrap Upper Arm Left Large SW-BL

GUDID 00856525007020

SunWrap™ Compression Sleeve are used to maintain pressure against a dressing covering, following a dialysis treatment for the needle sites in conjunction with an inflation source to provide static pneumatic compression to aid in the prevention of bleeding.

SUN SCIENTIFIC, INC.

Compression/pressure tubular garment

• Primary Device ID: 00856525007020
• NIH Device Record Key: 37f082d6-d7a2-4b78-931b-2ed018fec3c2
• Commercial Distribution Discontinuation: 2025-02-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunWrap Upper Arm Left Large
• Version Model Number: DA1150-01
• Catalog Number: SW-BL
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856525007020 [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: 2021-03-02
• Device Publish Date: 2021-02-22

Devices Manufactured by SUN SCIENTIFIC, INC.

• 00850051939565 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939572 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939589 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939596 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939602 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939619 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939626 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
• 00850051939640 - AeroWrap™ Full Leg: 2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k