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EsoCool

FDA UDI

Class II (US FDA UDI)

by Nuvaira, Inc.

Identity

Trade Name
EsoCool FDA UDI
Generic Name
General-body orifice lubricant FDA UDI
Device Name
EsoCool Esophageal Cooling Catheter, 60 cm FDA UDI
Model / Reference
ESC-60 FDA UDI
Description
EsoCool Esophageal Cooling Catheter, 60 cm FDA UDI

Identifiers

Primary DI / UDI-DI
00850041319018 FDA UDI
510(k) Number
K233357 FDA UDI
FDA Product Code
PLA FDA UDI
KMJ FDA UDI
GMDN Term
General-body orifice lubricant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5910 FDA UDI
880.6375 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 — 60 Centimeter FDA UDI

Category: General-body orifice lubricantCore temperature regulation orogastric tube

EsoCool by Nuvaira, Inc. — Class II — 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

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Manufacturer

Manufacturer
Nuvaira, Inc.

Sources (1)

  • FDA UDI 370f316c-10b4-4615-9cf8-c09d8a03406d 36 fields · synced May 31, 2026