REPEATER H93829

GUDID 50085412476549

REPEATER Pump Universal Spike, Sterile, Luer Lock

BAXTER CORPORATION ENGLEWOOD

Intravenous fluid bag spike

• Primary Device ID: 50085412476549
• NIH Device Record Key: 0568bfa4-e626-474b-b611-ce19a615fbdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REPEATER
• Version Model Number: H93829
• Catalog Number: H93829
• 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
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com
• Phone: +1(800)422-9837
• Email: cfs_customer_service@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412476544 [Primary]
GS1	50085412476549 [Package]; Contains: 00085412476544; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900585

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: 2016-09-23

On-Brand Devices [REPEATER]

• 50085412477003: REPEATER Pump Fluid Transfer Tube Set, Sterile, Std Volume, Low Priming
• 50085412476846: REPEATER Pump Extension Set, Male LL to Male LL
• 50085412476693: REPEATER Pump Fluid Transfer Tube Set, Sterile, Std Volume, Trifurcated
• 50085412476686: REPEATER Pump Fluid Transfer Tube Set, Sterile, Std Volume, Bifurcated Sets
• 50085412476594: REPEATER Pump Fluid Transfer Tube Set, Non-Vented Spike - Luer Lock
• 50085412476549: REPEATER Pump Universal Spike, Sterile, Luer Lock
• 50085412476525: REPEATER Pump Fluid Transfer Tube Set, Sterile, Std Volume, Luer Lock Ends
• 50085412476518: REPEATER Pump Fluid Transfer Tube Set, Non-Sterile
• 50085412475726: Sterile REPEATER Pump Tube Sets, Universal Spike - Luer Lock