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HydraTherm

FDA UDI

Class I (US FDA UDI)

by Compass Health Brands Corp.

Identity

Trade Name
HydraTherm FDA UDI
Generic Name
Hot therapy pack heating unit FDA UDI
Device Name
HydraTherm Heater-Deluxe, Divider Rack System, no packs (120V) FDA UDI
Model / Reference
HT-R12-D FDA UDI
Description
HydraTherm Heater-Deluxe, Divider Rack System, no packs (120V) FDA UDI

Identifiers

Primary DI / UDI-DI
00853904006780 FDA UDI
FDA Product Code
IRQ FDA UDI
GMDN Term
Hot therapy pack heating unit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hot therapy pack heating unit

HydraTherm by Compass Health Brands Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hot therapy pack heating unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Compass Health Brands Corp.

Sources (1)

  • FDA UDI eb390100-8c4b-4a48-8d8e-aba990d0c33b 34 fields · synced Jun 8, 2026