BERKELEY

GUDID 00821925038196

BERKELEY 1/2" (13 mm) PRIMARY COLLECTION BOTTLES (10/PK)

Gyrus ACMI, LLC

Surgical suction system collection container, single-use

• Primary Device ID: 00821925038196
• NIH Device Record Key: e1e656d7-4918-42f7-a27d-a63d97f31e4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BERKELEY
• Version Model Number: BKC-506
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00821925038196 [Primary]

FDA Product Code

• HHK: Curette, Suction, Endometrial (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 10
• Public Version Date: 2024-11-15
• Device Publish Date: 2016-10-13

Devices Manufactured by Gyrus ACMI, LLC

• 00821925037861 - BERKELEY SAFE-TOUCH: 2025-01-16 BERKELEY SAFE-TOUCH TISSUE TRAP (10/PK)
• 00821925038622 - Gyrus ACMI: 2025-01-15 Replacement Knob Assembly (4/PK)
• 00821925023895 - Gyrus ACMI: 2024-12-30 12 FOOT (3.66 meters) IRRIGATION TUBING
• 00821925007932 - Gyrus ACMI: 2024-12-25 Replacement Knob Assembly (4/PK)
• 00821925002630 - Gyrus ACMI: 2024-12-17 Fluid Pouch Disposable (12/PK)
• 00821925036147 - Gyrus ACMI: 2024-12-17 5 FR Open End Ureteral Catheter 5.0 FR (1.667 mm) X 70 cm (10/PK)
• 00821925002487 - USA Elite System: 2024-12-05 Semi-Rigid Gynecologic Alligator Forceps 7 Fr (2.3 mm), 42 CM
• 00821925046245 - Olympus: 2024-12-05 UDI, Digital Hub, ES-IP