CHEMO-AIDE 2N9106

GUDID 50085412035135

CHEMO-AIDE Dispensing Pin, Reconstitution/Dispensing Device with 0.2 Micron Hydrophobic/Oleophobic Air-Venting Filter and Female Luer Adapter

BAXTER INTERNATIONAL INC.

Medication transfer set

• Primary Device ID: 50085412035135
• NIH Device Record Key: e266bc2b-f079-416d-8b45-717a1459ce47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHEMO-AIDE
• Version Model Number: 2N9106
• Catalog Number: 2N9106
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL INC.
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412035130 [Primary]
GS1	50085412035135 [Package]; Contains: 00085412035130; Package: CASE [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003730

FDA Product Code

• LHI: Set, i.V. Fluid transfer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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