TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site MG412116

GUDID 27298119121168

TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

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• Primary Device ID: 27298119121168
• NIH Device Record Key: bed1fe19-5b08-41e5-a13c-a16dfb56ceb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site
• Version Model Number: MG412116
• Catalog Number: MG412116
• 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	07298119121164 [Unit of Use]
GS1	27298119121168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141306

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• 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: 2019-12-11TEVADAPTOR® Spike Port Adaptor 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