Device
OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera.
Manufacturer
RecensMedical, Inc.
RecensMedical, Inc.
Model: ODM-E01
DI: 08800073100124
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
88ee088a-b4dd-4a68-8003-6a738d871c08
Distribution Status:
In Commercial Distribution
DUNS Number:
694808508
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800073100124
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65476
Name: Ophthalmic injector/illuminating catheter
Definition:
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.
FDA Product Codes
QZQ
Ophthalmic Cooling Anesthesia Device
Premarket Submissions
Submission Number:
DEN230011
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling Low - @attributes - Value:
70
Item #1 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling High - @attributes - Value:
106
Item #1 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
80
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
15
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
30
Item #3 - Storage Handling Type:
Handling Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling Low - @attributes - Value:
50
Item #4 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling High - @attributes - Value:
106
Item #4 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #5 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling Low - @attributes - Value:
30
Item #5 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling High - @attributes - Value:
80
Item #5 - Storage Handling Type:
Storage Environment Humidity
Item #6 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling Low - @attributes - Value:
-40
Item #6 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling High - @attributes - Value:
70
Item #6 - Storage Handling Type:
Storage Environment Temperature