Delta Fly®

GUDID 58032248368168

Delta Fly Micro Bore Winged Safety Needle

DELTA MED SPA

Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set

• Primary Device ID: 58032248368168
• NIH Device Record Key: 7920e68e-2d18-43a4-af65-252c3219151b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta Fly®
• Version Model Number: 3681622
• Company DUNS: 444776777
• Company Name: DELTA MED SPA
• 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: true
• 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

Device Dimensions

• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge
• Outer Diameter: 0.6 Millimeter
• Length: 20 Millimeter
• Needle Gauge: 23 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	08032248368163 [Primary]
GS1	38032248368164 [Package]; Contains: 08032248368163; Package: Box [60 Units]; In Commercial Distribution
GS1	58032248368168 [Package]; Contains: 38032248368164; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140175

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2019-10-23
• Device Publish Date: 2016-09-23

On-Brand Devices [Delta Fly®]

• 58032248369127: Delta Fly Micro Bore Winged Safety Needle
• 58032248369028: Delta Fly Micro Bore F20 Winged Safety Needle
• 58032248368526: Delta Fly Micro Bore F20 Winged Safety Needle
• 58032248368168: Delta Fly Micro Bore Winged Safety Needle