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ThermoSuit System

FDA UDI

Class II (US FDA UDI)

by Life Recovery Systems Hd, LLC

Identity

Trade Name
ThermoSuit System FDA UDI
Generic Name
External circulating-fluid core temperature regulation system control unit, cooling-only FDA UDI
Model / Reference
18F Temperature Probe FDA UDI

Identifiers

Catalog Number
72005 FDA UDI
Primary DI / UDI-DI
00851936007089 FDA UDI
510(k) Number
K061023 FDA UDI
FDA Product Code
NZE FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system control unit, cooling-only 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External circulating-fluid core temperature regulation system control unit, cooling-only

ThermoSuit System by Life Recovery Systems Hd, 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 control unit, cooling-only.

Cleared under the same submission

K061023 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Life Recovery Systems Hd, LLC

Sources (1)

  • FDA UDI fdc68a01-2c9b-4f98-a880-64efa7cfce75 34 fields · synced May 30, 2026