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Moist Hot-Pack Unit

FDA UDI

Class I (US FDA UDI)

by KARIS Co., Ltd

Identity

Trade Name
Moist Hot-Pack Unit FDA UDI
Generic Name
Hot therapy pack heating unit FDA UDI
Device Name
It is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature. FDA UDI
Model / Reference
KRS-6P-A1D32 FDA UDI
Description
It is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature. FDA UDI

Identifiers

Primary DI / UDI-DI
08809520550437 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

Yes

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

Yes

FDA UDI

Category: Hot therapy pack heating unit

Moist Hot-Pack Unit by KARIS Co., Ltd — 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
KARIS Co., Ltd

Sources (1)

  • FDA UDI ef3f0416-c3b1-45a9-9c5f-6a66434bf468 34 fields · synced May 30, 2026