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Plastipad® Infant Size

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
Plastipad® Infant Size FDA UDI
Generic Name
External circulating-fluid core temperature regulation system pad, reusable FDA UDI
Device Name
Water Circulating Hot or Cold Pack FDA UDI
Model / Reference
193 FDA UDI
Description
Water Circulating Hot or Cold Pack FDA UDI

Identifiers

Catalog Number
82193 FDA UDI
Primary DI / UDI-DI
10613031821932 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5720 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 11.87 Inch FDA UDI
Length — 18.75 Inch FDA UDI
Weight — 1.4 Pound FDA UDI

Category: External circulating-fluid core temperature regulation system pad, reusable

Plastipad® Infant Size by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gentherm Medical, LLC

Sources (1)

  • FDA UDI 09e82561-4190-4431-9e43-afa57ef6bb28 37 fields · synced May 30, 2026