Churchill Medical Systems BHY-2010

GUDID 38498840010267

10" WINGED SAFETY INFUSION SET W/20 GA. X 1.0" HUBER NEEDLE AND NEEDLELESS Y-SITE

Vygon Corporation

Vascular port administration set

• Primary Device ID: 38498840010267
• NIH Device Record Key: 9d1955dc-a745-439a-a4a1-c3ef46fedd0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Churchill Medical Systems
• Version Model Number: BHY-2010
• Catalog Number: BHY-2010
• Company DUNS: 120818216
• Company Name: Vygon Corporation
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08498840010266 [Primary]
GS1	38498840010267 [Package]; Contains: 08498840010266; Package: [12 Units]; Discontinued: 2020-07-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020544

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: 2
• Public Version Date: 2020-07-31
• Device Publish Date: 2020-04-21

On-Brand Devices [Churchill Medical Systems]

• 38498840010540: 10" WINGED SAFETY INFUSION SET W/22 GA. X .75" HUBER NEEDLE AND NEEDLELESS Y-SITE
• 38498840010533: 10" WINGED SAFETY INFUSION SET W/22 GA. X .5" HUBER NEEDLE
• 38498840010526: 10" WINGED SAFETY INFUSION SET W/22 GA. X .75" HUBER NEEDLE
• 38498840010519: 10" WINGED SAFETY INFUSION SET W/20 GA. X .75" (19MM) HUBER NEEDLE
• 38498840010731: 10" WINGED SAFETY INFUSION SET W/20 GA. X 1.0" HUBER NEEDLE
• 38498840010380: 10" WINGED SAFETY INFUSION SET W/22 GA. X 1.0" HUBER NEEDLE AND NEEDLELESS Y-SITE
• 38498840010373: 10" WINGED SAFETY INFUSION SET W/20 GA. X .75" HUBER NEEDLE AND NEEDLELESS Y-SITE
• 38498840010267: 10" WINGED SAFETY INFUSION SET W/20 GA. X 1.0" HUBER NEEDLE AND NEEDLELESS Y-SITE