TEVADAPTOR® Spike Port Adaptor MG412113

GUDID 27298119121137

TEVADAPTOR® Spike Port Adaptor for use with OnGuardTM contained Medication System

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Medication transfer set

• Primary Device ID: 27298119121137
• NIH Device Record Key: e08d31db-2957-4853-af79-0c4f36ef15da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEVADAPTOR® Spike Port Adaptor
• Version Model Number: MG412113
• Catalog Number: MG412113
• Company DUNS: 600029649
• Company Name: TEVA PHARMACEUTICAL INDUSTRIES LIMITED
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07298119121133 [Unit of Use]
GS1	27298119121137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141448

FDA Product Code

• ONB: Closed antineoplastic and hazardous drug reconstitution and transfer system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

Devices Manufactured by TEVA PHARMACEUTICAL INDUSTRIES LIMITED

• 27298119121151 - TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site: 2019-12-11 TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System
• 27298119121168 - TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site: 2019-12-11 TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System
• 27298119121205 - TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Inj. Site: 2019-12-11 TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System
• 27298119121113 - TEVADAPTOR® Vial Adaptor: 2018-07-06 TEVADAPTOR® 20 mm Vial Adaptor and 13mm converter for use with OnGuardTM contained Medication System
• 27298119121144 - TEVADAPTOR® Luer Lock Adaptor: 2018-07-06 TEVADAPTOR® Luer Lock Adaptor for use with OnGuardTM contained Medication System
• 27298119121182 - TEVADAPTOR® Syringe Adaptor: 2018-07-06 TEVADAPTOR® Syringe Adaptor HF for use with OnGuardTM contained Medication System
• 27298119121199 - TEVADAPTOR® 28mm Vial Adaptor: 2018-07-06 TEVADAPTOR® 28mm Vial Adaptor for use with OnGuardTM contained Medication System
• 27298119121120 - TEVADAPTOR® Connecting Set: 2018-07-06 TEVADAPTOR® Connecting Set for use with OnGuardTM contained Medication System