AT 030

GUDID 04049471090260

he AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagno

Carl Zeiss Meditec AG

Ophthalmic slit lamp, examination

• Primary Device ID: 04049471090260
• NIH Device Record Key: 78de1a12-3561-4983-81cd-818f93890fa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AT 030
• Version Model Number: AT 030
• Company DUNS: 314594680
• Company Name: Carl Zeiss Meditec AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage w/o packaging: temperature -10°C to +55°C; rel. humidity 10%-95%

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471090260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180839

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-04
• Device Publish Date: 2018-12-04

Devices Manufactured by Carl Zeiss Meditec AG

• 04049471097153 - SL 220: 2026-01-21 An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithe
• 04049539105509 - INTRABEAM Spherical Sizer Set: 2025-06-30 The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therap
• 04049539105516 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105523 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105530 - INTRABEAM SMART Spherical Applicator: 2025-05-22
• 04049539105547 - INTRABEAM SMART Spherical Applicator (35 mm): 2025-05-22
• 04049539105554 - INTRABEAM SMART Spherical Applicator (35mm): 2025-05-22
• 04049539105561 - INTRABEAM SMART Spherical Applicator (40mm): 2025-05-22