AT 030

Basic Information

• Brand Name: AT 030
• Primary DI: 04049471090260
• Version / Model: AT 030
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 314594680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-04
• Public Version: 4
• Public Version Date: 2026-01-14
• Public Version Status: Update
• Public Device Record Key: 78de1a12-3561-4983-81cd-818f93890fa7

Device Description

The AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKY	Tonometer, Manual	Ophthalmic	886.1930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35148	Ophthalmic examination slit lamp	An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049471090260	GS1

Premarket Submissions

Submission Number	Supplement Number
K180839	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			AT 030 for SL 120, SL 130 and SL 220: 105 mm x 40 mm x 25 mm
Device Size Text, specify			AT 030 for SL 800: 270 mm x 67 mm x 168 mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%