Therm-X TX0104

GUDID 00850001096041

Therm-X Ankle Garment

ZENITH TECHNICAL INNOVATIONS, LLC

Inflatable hot/cold therapy pack/electric pump
Primary Device ID00850001096041
NIH Device Record Keyd15afdfe-2066-4444-8185-2ead7c10ab9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTherm-X
Version Model NumberTherm-X Ankle Garment
Catalog NumberTX0104
Company DUNS062931546
Company NameZENITH TECHNICAL INNOVATIONS, LLC
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

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001096041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-22
Device Publish Date2018-09-17

On-Brand Devices [Therm-X]

00850001096089Therm-X Foot DVT Garment
00850001096072Therm-X Calf DVT Garment
00850001096065Therm-X Shoulder Garment
00850001096058Therm-X Elbow Garment
00850001096041Therm-X Ankle Garment
00850001096034Therm-X Knee Garment
00850001096027Therm-X Back Garment
00850001096010Therm-X AT
00850001096003Therm-X Pro
00850001096164Therm-X Split Umbilical Hose
00850001096096Therm-X Umbilical Hose
00850001096171Therm-X Hip Garment
00850001096232Therm-X Back SPU
00850001096225Therm-X Hip SPU
00850001096218Therm-X Ankle SPU
00850001096201Therm-X Knee SPU
00850001096195Therm-X Shoulder SPU
00850001096188Therm-X HOME
00850001096157Therm-X Power Supply and Cord (Medical Grade)

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