IDESIGN RS 0110-3521

GUDID 05050474620278

PACK IN, IDESIGN, VISION TABLE UPGRADE

JOHNSON & JOHNSON SURGICAL VISION, INC.

Ophthalmic refractometer, manual

• Primary Device ID: 05050474620278
• NIH Device Record Key: 4901806c-3081-42d5-93e1-64c1d64b3594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDESIGN RS
• Version Model Number: G301
• Catalog Number: 0110-3521
• Company DUNS: 010130626
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM
• Phone: +1(877)266-4543
• Email: JJV-US-SURGICALORDERS@ITS.JNJ.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 35 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05050474620278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P930016

FDA Product Code

• LZS: Excimer laser system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-26
• Device Publish Date: 2018-08-21

On-Brand Devices [IDESIGN RS]

• 05050474651456: KIT, IDESIGN RS UPGRADE, US
• 05050474651449: ASSY, CRATED, TABLE, VISION
• 05050474651432: IDESIGN REFRACTIVE STUDIO ABERROMETER US
• 05050474620278: PACK IN, IDESIGN, VISION TABLE UPGRADE