← Back to catalogue

EsoCool

FDA UDI

Class I (US FDA UDI)

by Nuvaira, Inc.

Identity

Trade Name
EsoCool FDA UDI
Generic Name
Core temperature regulation orogastric tube FDA UDI
Device Name
EsoCool Esophageal Cooling Catheter, 40 cm FDA UDI
Model / Reference
ESC-40 FDA UDI
Description
EsoCool Esophageal Cooling Catheter, 40 cm FDA UDI

Identifiers

Primary DI / UDI-DI
00850041319001 FDA UDI
510(k) Number
K233357 FDA UDI
FDA Product Code
KMJ FDA UDI
PLA FDA UDI
GMDN Term
Core temperature regulation orogastric tube FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6375 FDA UDI
870.5910 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

Yes

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

Dimensions & Sizes

Size
Catheter Working Length — 40 Centimeter FDA UDI

Category: General-body orifice lubricantCore temperature regulation orogastric tube

EsoCool by Nuvaira, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Core temperature regulation orogastric tube.

Cleared under the same submission

K233357 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nuvaira, Inc.

Sources (1)

  • FDA UDI 29f3f150-f3ea-4785-a261-2678c8d733e6 36 fields · synced May 29, 2026