AGPI 17565-10

GUDID 20841305109944

Adjustable Gas Pressured Infusion Tubing Set

SYNERGETICS USA, INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 20841305109944
• NIH Device Record Key: 679bba44-39a8-4398-b1e7-824e16677611
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGPI
• Version Model Number: 17565-10
• Catalog Number: 17565-10
• Company DUNS: 021056726
• Company Name: SYNERGETICS USA, INC.
• Device Count: 10
• DM Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841305109930 [Unit of Use]
GS1	20841305109944 [Primary]

FDA Product Code

• MSR: Tubing, Replacement, Phacofragmentation Unit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-17

Devices Manufactured by SYNERGETICS USA, INC.

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• 20841305107636 - Synergetics: 2025-04-04 Replacement Backflush Reservoir
• 20841305107643 - Synergetics: 2025-04-04 Awh Lens Ring
• 20841305107711 - Synergetics: 2025-04-04 Three-Way Infusion Tubing Set
• 20841305107735 - Synergetics: 2025-04-04 Hubbard Visco Dissector
• 20841305107780 - Synergetics: 2025-04-04 Standard Tubing Set
• 20841305107797 - Synergetics: 2025-04-04 Aspiration Tubing Set
• 20841305107803 - Synergetics: 2025-04-04 Air/Fluid Exchange Line