Duplex

GUDID 30843356101066

DUAL-CAVITY instrument transport bag

CYGNUS MEDICAL L.L.C.

Instrument hygienic-transportation bag

• Primary Device ID: 30843356101066
• NIH Device Record Key: d85f9828-4142-424f-973f-76a19e69792d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duplex
• Version Model Number: DCB2017
• Company DUNS: 103169095
• Company Name: CYGNUS MEDICAL L.L.C.
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843356101065 [Primary]
GS1	30843356101066 [Unit of Use]

FDA Product Code

• PXV: General Purpose Instrument Tray

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: 2023-07-10
• Device Publish Date: 2023-06-30

Devices Manufactured by CYGNUS MEDICAL L.L.C.

• 00843356102857 - CYGNUS: 2025-07-21 CLEAN CHEMO DUAL LAYER LABEL 500 PER CASE
• 00843356102864 - CYGNUS: 2025-07-21 Slip Connector 500 per case
• 00843356101812 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12: 2025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R Version on Gator Clips - All cli
• 00843356101829 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12: 2025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R version on Gator Clips - All cli
• 10843356102694 - CYGNUS: 2024-12-19 Tip Gard 500 Per Bag, 2000 Per Case
• 90843356102744 - CYGNUS: 2024-11-28 Enhanced Coating Single Cycle, EC0308 100 per case
• 90843356102751 - CYGNUS: 2024-11-28 Enhanced Coating Single Cycle, EC0308 with label 100 per case
• 90843356102768 - CYGNUS: 2024-11-28 Enhanced Coating Single Cycle, EC0612 100 per case