HTP1500 HTP1500

GUDID 10615089310109

Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free

ADROIT MEDICAL SYSTEMS, INC.

Circulating-fluid localized thermal therapy system control unit
Primary Device ID10615089310109
NIH Device Record Key1aad0288-f366-4a58-905b-6b9d739617df
Commercial Distribution StatusIn Commercial Distribution
Brand NameHTP1500
Version Model NumberHTP1500
Catalog NumberHTP1500
Company DUNS795104769
Company NameADROIT MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110615089310109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILOPack, Hot Or Cold, Water Circulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-12-18
Device Publish Date2016-09-23

On-Brand Devices [HTP1500]

10615089311106Accessory Rolling Stand for HTP1500 Pump
10615089310109Heat Pump Hyperthermia 10in x 7in Dia. Digital Display Mercury Free

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.