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Stx Surface Cooling

FDA UDI

Class I (US FDA UDI)

by ZOLL Circulation, Inc.

Identity

Trade Name
STX SURFACE COOLING FDA UDI
Generic Name
External circulating-fluid core temperature regulation system pad, single-use FDA UDI
Device Name
STX SURFACE COOLING Pad L/XL PAD SET FDA UDI
Model / Reference
L/XL PAD FDA UDI
Description
STX SURFACE COOLING Pad L/XL PAD SET FDA UDI

Identifiers

Catalog Number
8700-000839-01 FDA UDI
Primary DI / UDI-DI
00849111076104 FDA UDI
FDA Product Code
FOH FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

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

Stx Surface Cooling by ZOLL Circulation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZOLL Circulation, Inc.

Sources (1)

  • FDA UDI 5b48cc7d-5a12-490a-becd-a6b39f303811 35 fields · synced Jun 9, 2026