Churchill Medical Systems BHS-2010

GUDID 38498840010731

10" WINGED SAFETY INFUSION SET W/20 GA. X 1.0" HUBER NEEDLE

Vygon Corporation

Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set

• Primary Device ID: 38498840010731
• NIH Device Record Key: ee890129-76af-48ce-bfbf-24fc51278076
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Churchill Medical Systems
• Version Model Number: BHS-2010
• Catalog Number: BHS-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	08498840010730 [Primary]
GS1	38498840010731 [Package]; Contains: 08498840010730; 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: 2020-05-21

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