Home GUDID 08800073100124 OcuCool
Primary DI 08800073100124
Brand OcuCool
Company RecensMedical, Inc.
Model ODM-E01
Device description OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera.
Published 2026-05-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QZQ Ophthalmic Cooling Anesthesia Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QZQ Ophthalmic Cooling Anesthesia Device
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800073100124 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800073100124 08800073100124 8800073100124
GMDN Terms# Term, Definition table Term Definition Ophthalmic injector/illuminating catheter A non-electric, hand-held, fibreoptic, device intended for controlled manual intraocular infusion of a fluid (e.g., viscoelastic substance), while facilitating illumination of the interior of the eye, during an ophthalmic surgical procedure (e.g., viscodilation of Schlemm’s canal). It includes a very thin and flexible tube (microcatheter) with an incorporated fibreoptic bundle and a manual fluid injector; it is designed for connection to a light source (not included). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 30 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 694808508 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company#