HTP1500 Accessory 3116-0001

GUDID 10615089311601

Circulating-fluid localized thermal therapy system control unit

Primary Device ID	10615089311601
NIH Device Record Key	4ca25987-75c2-4ef2-b018-19e9b002824c
Commercial Distribution Status	In Commercial Distribution
Brand Name	HTP1500 Accessory
Version Model Number	TFR-1
Catalog Number	3116-0001
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	false
Lot Batch	false
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 Issuing Agency	Device ID
GS1	10615089311601 [Primary]

ILO	Pack, Hot Or Cold, Water Circulating

Steralize Prior To Use	false
Device Is Sterile	false

10615089310147 - Accessory; HTP-1500 Replacement Cap	2024-12-25 Replacement Black Cap for HTP-1500
20615089100301 - Soft-Temp	2023-12-18 Pad Heat Neck 4 x 19 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable.
20615089100400 - Soft-Temp	2023-12-18 Neck Pad, insulated, Velcro Fastener
20615089100806 - Soft-Temp	2023-12-18 Pad for Motorized Cold Therapy Foot Non-Sterile 6x8in.
20615089101001 - Soft-Temp	2023-12-18 Pad for Motorized Cold Therapy Unit Hand Non-Sterile 5x10in.
20615089101209 - Soft-Temp	2023-12-18 Pad for Motorized Cold Therapy Knee Non-Sterile 12x12in.
20615089101407 - Soft-Temp	2023-12-18 Pad for Motorized Cold Therapy Unit Thigh Non-Sterile 8x14in.
20615089101704 - Soft-Temp	2023-12-18 Pad Heat Small 12 x 17 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable