ThermaCor 1200 Infusion System

FDA UDI

Class II (US FDA UDI)

by Smisson-Cartledge Biomedical, LLC

Identity

Trade Name: ThermaCor 1200 Infusion System FDA UDI
Generic Name: Conduction blood/fluid warmer FDA UDI
Device Name: Replacement Silpad FDA UDI
Model / Reference: SP-1200 FDA UDI
Description: Replacement Silpad FDA UDI

Identifiers

Primary DI / UDI-DI: 00857893006035 FDA UDI
510(k) Number: K052055 FDA UDI
FDA Product Code: LGZ FDA UDI
FRN FDA UDI
GMDN Term: Conduction blood/fluid warmer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Conduction blood/fluid warmer

ThermaCor 1200 Infusion System by Smisson-Cartledge Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conduction blood/fluid warmer.

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ASTOLINE — Stihler Electronic GmbH · Class II
ASTOTHERM® PLUS — Stihler Electronic GmbH · Class II
EXPRESS FLUID WARMER — NxStage Medical, Inc. · Class II
°M Warmer System - Charger — Mequ A/S · Class II
ASTOFLO® PLUS ECO — Stihler Electronic GmbH · Class II
QINFLOW AC STATION INTRO SET WARRIOR — QUALITY IN FLOW LTD · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Smisson-Cartledge Biomedical, LLC

Sources (1)

FDA UDI 73d1f34a-6cf4-4906-8ad2-02c35860e8b8 35 fields · synced Jun 8, 2026