Transystem™ 190C.USE

GUDID 38053326001216

TRANSYSTEM AMIES W/O CH. TWISTED APPLICATOR RAYON TIPPED

COPAN ITALIA SPA

General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit

• Primary Device ID: 38053326001216
• NIH Device Record Key: 976bd769-1855-4516-ad39-5e31bdc747be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transystem™
• Version Model Number: 190C.USE
• Catalog Number: 190C.USE
• 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	18053326001212 [Unit of Use]
GS1	28053326001219 [Primary]
GS1	38053326001216 [Package]; Contains: 28053326001219; 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 [Transystem™ ]

• 58053326009957: TRANSYSTEM LQ AMIES DUAL APPLICATORS RAYON TIPPED
• 58053326005355: TRANSYSTEM LIQUID AMIES TWISTED APLICATOR RAYON TIPPED
• 38053326004910: TRANSYSTEM AMIES W/CH SOFT ALUMINIUM APPLICATOR RAYON TIPPED
• 38053326001575: TRANSYSTEM AMIES W/O CH PLASTIC APPLICATOR RAYON TIPPED
• 38053326001568: TRANSYSTEM LQ AMIES DUAL APPLICATORS POLYESTER SWABS
• 38053326001551: TRANSYSTEM LIQUID AMIES PLASTIC STICK POLYESTER TIPPED
• 38053326001520: TRANSYSTEM LQ STUART DUAL APPLICATOS BREAKABLE POINT 33mm
• 38053326001216: TRANSYSTEM AMIES W/O CH. TWISTED APPLICATOR RAYON TIPPED
• 38053326000875: TRANSYSTEM CARY BLAIR MEDIUM PLASTIC APPLICATOR RAYON TIPPED
• 38053326000868: TRANSYSTEM AMIES WITH CH ALUMINIUM APPLICATOR RAYON TIPPED
• 38053326000844: TRANSYSTEM AMIES W/O CH ALUMINIUM APPLICATOR RAYON TIPPED
• 38053326000608: TRANSYSTEM AMIES WITH CH PLASTIC APPLICATOR RAYON TIPPED
• 38053326000592: TRANSYSTEM AMIES W/O CH ALUMINIUM APPLICATOR RAYON TIPPED
• 38053326000585: TRANSYSTEM AMIES W/O CH PLASTIC APPLICATOR RAYON TIPPED
• 58053326009827: TRANSYSTEM AMIES W/CH. DUAL PLASTIC APPLICATOR RAYON TIPPED
• 38053326000905: TRANSYSTEM LQ STUART PLASTIC APPLICATOR RAYON TIPPED
• 38053326000899: TRANSYSTEM LQ AMIES PLASTIC APPLICATOR RAYON TIPPED
• 38053326000882: TRANSYSTEM LQ STUART DUAL PLASTIC APPLICATORS RAYON TIPPED