Honan Intraocular Pressure Reducer

GUDID 00851607007226

GAUGE (LATEX FREE), CASE, SILICONE TUBING WITH 1 BOX (12) DISPOSABLE BELLOWS & HEADBANDS

LEBANON CORP, THE

Intraocular pressure-reducing system

• Primary Device ID: 00851607007226
• NIH Device Record Key: 1552da83-6a3c-4e47-988a-659055b409f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Honan Intraocular Pressure Reducer
• Version Model Number: 3000
• Company DUNS: 093218832
• Company Name: LEBANON CORP, THE
• 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: true
• Lot Batch: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851607007226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820526

FDA Product Code

• LCC: Applicator, Ocular Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [Honan Intraocular Pressure Reducer]

• 00851607007257: LUER ADAPTER
• 00851607007240: SILICONE TUBING
• 00851607007233: GAUGE (LATEX FREE), CASE, SILICONE TUBING + RELIEF VALVE WITH 1 BOX (12) DISPOSABLE BELLOWS & HE
• 00851607007226: GAUGE (LATEX FREE), CASE, SILICONE TUBING WITH 1 BOX (12) DISPOSABLE BELLOWS & HEADBANDS
• 00851607007219: 1 BOX (12) SINGLE USE DISPOSABLE BELLOWS & HEADBANDS
• 00851607007202: CASE, BLACK W/ ZIPPER
• 00851607007196: BLACK BULB W/ FILTER & RING (NEW STYLE)
• 00851607007189: BLUE BULB - AIR PUMP (LATEX FREE)
• 00851607007172: BLACK BULB - AIR PUMP(LATEX)
• 00851607007165: SCREWS FOR PALM REST (EACH)
• 00851607007158: CHECK VALVE (ONE PIECE DESIGN)
• 00851607007141: CHECK VALVE FILTER (OLD STYLE)
• 00851607007134: CHECK VALVE (NEW STYLE)
• 00851607007127: FERRULE
• 00851607007110: FERRULE & LUER CONNECTOR
• 00851607007103: CRYSTAL (PLASTIC GAUGE COVER)
• 00851607007097: KNURLED KNOB
• 00851607007080: PRESSURE GAUGE & BLUE BULB AIR PUMP (LATEX FREE)
• 00851607007073: PRESSURE GAUGE & BLACK BULB AIR PUMP (LATEX)
• 00851607007066: RELIEF VALVE
• 00851607007059: TUBING
• 00851607007042: DIVIDED HEADBAND
• 00851607007035: SINGLE HEADBAND
• 00851607007028: BELLOWS (REUSABLE)
• 00851607007011: GAUGE, CASE, TUBING, WITH REUSABLE BELLOWS & HEADBAND + RELIEF VALVE
• 00851607007004: GAUGE, CASE, TUBING, WITH REUSABLE BELLOWS & HEADBAND