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Pintler Patient Warming System

FDA UDI

Class II (US FDA UDI)

by Pintler Medical

Identity

Trade Name
Pintler Patient Warming System FDA UDI
Generic Name
External electric-heating core temperature regulation system pad FDA UDI
Device Name
The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit . The operating room pad utilizes a low voltage heating element and warms patients with conductive warming technology. The system aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired FDA UDI
Model / Reference
PPWS001 FDA UDI
Description
The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit . The operating room pad utilizes a low voltage heating element and warms patients with conductive warming technology. The system aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired FDA UDI

Identifiers

Catalog Number
PPWS001 FDA UDI
Primary DI / UDI-DI
B389PPWS0011 FDA UDI
510(k) Number
K113705 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External electric-heating core temperature regulation system pad FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External electric-heating core temperature regulation system padExternal electric-heating core temperature regulation system control unit

Pintler Patient Warming System by Pintler Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External electric-heating core temperature regulation system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pintler Medical

Sources (1)

  • FDA UDI d0f276c3-02a1-41c6-98ef-a57775686c71 36 fields · synced Jun 8, 2026