visionPRO Mac 4

GUDID 04053755200054

Heine Optotechnik GmbH & Co. KG

Laryngoscope blade, single-use

• Primary Device ID: 04053755200054
• NIH Device Record Key: df7e79ef-c37d-49a5-a8a7-81de863839a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: visionPRO Mac 4
• Version Model Number: 000
• Company DUNS: 315274563
• Company Name: Heine Optotechnik GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com
• Phone: +1 (603) 742-7103
• Email: service@heine-na.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053755199938 [Primary]
GS1	04053755200054 [Package]; Contains: 04053755199938; Package: box [10 Units]; In Commercial Distribution
GS1	04053755200078 [Package]; Contains: 04053755199938; Package: box [50 Units]; In Commercial Distribution

FDA Product Code

• CCW: Laryngoscope, Rigid

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: 2022-11-17
• Device Publish Date: 2022-11-09

Devices Manufactured by Heine Optotechnik GmbH & Co. KG

• 04053755136988 - GAMMA 3.1: 2024-11-25
• 04053755136995 - GAMMA 3.2: 2024-11-25
• 04053755137015 - GAMMA 3.3: 2024-11-25
• 04053755137039 - GAMMA C.3: 2024-11-25
• 04053755179206 - BETA 400 LED F.O. OTOSCOPE: 2024-08-14
• 04053755201853 - visionPRO Mac 2: 2024-08-14
• 04053755202423 - MINI3000 LED OTOSCOPE: 2024-08-14 available also in blue
• 04053755202508 - BETA 200 LED RETINOSCOPE: 2024-07-24