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Smartfreeze™

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
SMARTFREEZE™ FDA UDI
Generic Name
Continuous electronic patient thermometer, line-powered FDA UDI
Device Name
Esophageal Temperature Sensor Cable FDA UDI
Model / Reference
M004CRBS6340 FDA UDI
Description
Esophageal Temperature Sensor Cable FDA UDI

Identifiers

Catalog Number
M004CRBS6340 FDA UDI
Primary DI / UDI-DI
00191506015718 FDA UDI
FDA Product Code
DRF FDA UDI
GMDN Term
Continuous electronic patient thermometer, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1220 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Continuous electronic patient thermometer, line-powered

Smartfreeze™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Continuous electronic patient thermometer, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 6bbb747b-b76b-47ee-a0fb-15b9c8637c14 34 fields · synced Jun 6, 2026