Soft-Temp ST-050

GUDID 20615089105009

Head Wrap

ADROIT MEDICAL SYSTEMS, INC.

Circulating-fluid localized thermal therapy system pack, single-use

• Primary Device ID: 20615089105009
• NIH Device Record Key: 16b34bd9-f4a0-4b91-ab79-11e4a4e7aa16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soft-Temp
• Version Model Number: ST-050
• Catalog Number: ST-050
• Company DUNS: 795104769
• Company Name: ADROIT MEDICAL SYSTEMS, 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: true
• 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: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com
• Phone: 865-458-8600
• Email: scott@adroitmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10615089105002 [Primary]
GS1	20615089105009 [Package]; Contains: 10615089105002; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [Soft-Temp]

• 10615089620208: Accessory Hose Set for Baxter/Gaymar/Stryker Units
• 10615089620109: Accessory Hose Set for CSZ Unit
• 20615089126004: Blanket Adult 24x60in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric Both
• 20615089123003: Blanket Pediatric 24x30in (Filled Dimensions) Hyper-Hypothermia Non-Woven Medium Weight Fabric B
• 20615089122402: Pad Heat Large 18x24in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC F
• 20615089122006: Pad Heat Medium 14x20in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC
• 20615089121702: Pad Heat Small 12x17in (Filled Dimensions) Non-Woven Medium Weight Fabric Both Sides Latex/PVC F
• 20615089121207: Pad for Motorized Cold Therapy Unit Shoulder Non-Sterile 12x12in w/straps.
• 20615089116005: Blanket Adult 24x60 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free disposa
• 20615089113004: Blanket Pediatric 24x30 in. (Filled Dimensions) Hyper-Hypothermia All Polymer Latex/PVC Free Dis
• 10615089112406: Pad Heat Large 18x24in (Filled Dimensions) All Polymer Latex/PVC Free Disposable.
• 20615089112007: Pad Heat Medium 14x20 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable
• 20615089111703: Pad Heat Small 12x17 in (Filled Dimensions) All Polymer Latex/PVC Free Disposable
• 10615089109109: Accessory Thermometer for Temp Probe Adapter Cable Esophageal Rectal Probe
• 10615089107006: Cool Kit w/Head Wrap, Patient Vest and Blanket Wrap for Legs
• 10615089106009: Blanket Adult 24x60 in. (Filled Dimensions); Hyper-Hypothermia Non-Woven Fabric Both Sides; Late
• 20615089105009: Head Wrap
• 20615089104408: Patient Vest, Poncho Style, Elastic Straps
• 20615089104309: Leg Pad, 12 x 14.5 in. , Elastic Mesh
• 20615089104101: Arm Pad 8.5 x 9.5 in. Elastic Mesh.
• 10615089104005: Hyper-Hypothermia Patient Vest.
• 10615089103107: Leg Wrap
• 20615089103005: ST-030
• 20615089102602: Leg Pad, Insulated, Velcro Fasteners.
• 20615089102404: Pad Heat Large 18 x 24 in (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposa
• 20615089102107: Wrist Pad, Insulated, Velcro Fasteners
• 20615089102008: ST-020
• 20615089101902: Ankle Pad, Insulated, Velcro Fasteners.
• 20615089101803: Pad for Motorized Cold Therapy Unit Back Non-Sterile 12x17in.
• 20615089101704: Pad Heat Small 12 x 17 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Dispos
• 20615089101407: Pad for Motorized Cold Therapy Unit Thigh Non-Sterile 8x14in.
• 20615089101209: Pad for Motorized Cold Therapy Knee Non-Sterile 12x12in.
• 20615089101001: Pad for Motorized Cold Therapy Unit Hand Non-Sterile 5x10in.
• 20615089100806: Pad for Motorized Cold Therapy Foot Non-Sterile 6x8in.
• 20615089100400: Neck Pad, insulated, Velcro Fastener
• 20615089100301: Pad Heat Neck 4 x 19 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposab