TransPorter® 4190

GUDID 58053326008875

AMIES W/O CH (BLUE CAP) TWISTED WIRE STICK RAYON TIPPED

COPAN ITALIA SPA

General specimen collection kit

• Primary Device ID: 58053326008875
• NIH Device Record Key: 99b20238-f7fd-473f-b23b-f51d5d6a7d3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransPorter®
• Version Model Number: 4190
• Catalog Number: 4190
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 50
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053326008877 [Unit of Use]
GS1	38053326008871 [Primary]
GS1	58053326008875 [Package]; Contains: 38053326008871; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972448

FDA Product Code

• JSL: Culture Media, Anaerobic Transport

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [TransPorter® ]

• 58053326008950: SINGLE LQ AMIES (RED) PLASTIC APPLICATOR POLYESTER TIPPED
• 58053326008936: DOUBLE LQ AMIES (RED) TWO PLASTIC APPLICATORS POLYESTER TIPPED
• 58053326008912: "SINGLE STUART W/O CH(BLUE) PLASTIC STICK RAYON TIPPED "
• 58053326008899: SINGLE AMIES W/CH (BLUE) TWISTED APPLICATOR
• 58053326008875: AMIES W/O CH (BLUE CAP) TWISTED WIRE STICK RAYON TIPPED
• 58053326008868: SINGLE LIQUID STUART(ORANGE) ALUMINIUM APPLICATOR
• 58053326008851: SINGLE LIQUID AMIES(ORANGE) ALUMINIUM APPLICATOR RAYON TIPPED
• 58053326008844: SINGLE LQ STUART WHITE PLASTIC APPLICATOR RAYON TIPPED
• 58053326008837: SINGLE LQ AMIES(WHITE) PLASTIC APPLICATOR RAYON TIPPED
• 58053326008820: DUAL LIQUID STUART(RED) TWO PLASTIC STICK RAYON TIP
• 58053326008813: DOUBLE LQ AMIES(RED) TWO PLASTIC STICK RAYON TIPPED
• 58053326008806: DUAL AMIES W/CH (WHITE) TWO PLASTIC APPLICATORS
• 58053326008790: DUAL AMIES W/O CH(BLUE) TWO PLASTIC STICK RAYON TIP
• 58053326008783: SINGLE CARY BLAIR(RED) PLASTIC STICK RAYON TIPPED
• 58053326008776: MINI-TIP LIQ. STUART (GREEN) SOFT ALUMINIUM RAYON TIP
• 58053326008769: SINGLE AMIES W/CH (GREEN) SOFT ALUMINIUM RAYON TIPPE
• 58053326008752: SINGLE AMIES W/O CH(GREEN) SOFT ALUMINIUM STICK RAYON TIPPED
• 58053326008745: SINGLE AMIES W/O CH(ORANGE) ALUMINIUM APPLICATOR
• 58053326008738: SINGLE AMIES W/CH (ORANGE) ALUMINIUM STICK RAYON TIP
• 58053326008721: SINGLE AMIES W/CH (BLACK) PLASTIC RAYON TIPPED
• 58053326008714: SINGLE AMIES W/O CH(BLUE) PLASTIC STICK RAYON TIPPED
• 58053326008943: LIQUID STUART
• 58053326008929: SINGLE STUART W/O CH (ORANGE)