Accessory; HTP-1500 Replacement Cap 3101-4001

GUDID 10615089310147

Replacement Black Cap for HTP-1500

ADROIT MEDICAL SYSTEMS, INC.

Circulating-fluid localized thermal therapy system control unit
Primary Device ID10615089310147
NIH Device Record Keyb1e66c5c-989d-4b14-97db-fc51ac5e5efc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccessory; HTP-1500 Replacement Cap
Version Model NumberHTP-1500 Replacement Cap
Catalog Number3101-4001
Company DUNS795104769
Company NameADROIT MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com
Phone865-458-8600
Emailkelley@adroitmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110615089310147 [Primary]

FDA Product Code

ILOPack, Hot Or Cold, Water Circulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-25
Device Publish Date2024-12-17

Devices Manufactured by ADROIT MEDICAL SYSTEMS, INC.

10615089310147 - Accessory; HTP-1500 Replacement Cap2024-12-25Replacement Black Cap for HTP-1500
10615089310147 - Accessory; HTP-1500 Replacement Cap2024-12-25 Replacement Black Cap for HTP-1500
20615089100301 - Soft-Temp2023-12-18 Pad Heat Neck 4 x 19 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable.
20615089100400 - Soft-Temp2023-12-18 Neck Pad, insulated, Velcro Fastener
20615089100806 - Soft-Temp2023-12-18 Pad for Motorized Cold Therapy Foot Non-Sterile 6x8in.
20615089101001 - Soft-Temp2023-12-18 Pad for Motorized Cold Therapy Unit Hand Non-Sterile 5x10in.
20615089101209 - Soft-Temp2023-12-18 Pad for Motorized Cold Therapy Knee Non-Sterile 12x12in.
20615089101407 - Soft-Temp2023-12-18 Pad for Motorized Cold Therapy Unit Thigh Non-Sterile 8x14in.
20615089101704 - Soft-Temp2023-12-18 Pad Heat Small 12 x 17 in. (Filled Dimensions) Non-Woven Fabric Both Sides Latex/PVC Free Disposable

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