TWOFER H93816004

GUDID 50085412478390

TWOFER Huber-Tipped Needle

BAXTER CORPORATION ENGLEWOOD

Medication transfer needle, non-filtering/non-vented

• Primary Device ID: 50085412478390
• NIH Device Record Key: 83224ccf-3283-47be-927e-aecd8535c5b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TWOFER
• Version Model Number: H93816004
• Catalog Number: H93816004
• Company DUNS: 078383477
• Company Name: BAXTER CORPORATION ENGLEWOOD
• 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: true
• 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 Dimensions

• Needle Gauge: 16 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412478395 [Primary]
GS1	50085412478390 [Package]; Contains: 00085412478395; Package: CASE [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832347

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: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-09-24

On-Brand Devices [TWOFER]

• 20085412478429: TWOFER Huber-Tipped Needle
• 50085412478413: TWOFER Huber-Tipped Needle
• 50085412478406: TWOFER Huber-Tipped Needle
• 50085412478390: TWOFER Huber-Tipped Needle