DOSI-FLOW

GUDID 18436020769167

Regulator Extension Set with Female Luer Connector, Flow Regulator, Needle-Free Injection Site, and Rotating Luer Lock Connector

LEVENTON SAU

Basic intravenous administration set, noninvasive

• Primary Device ID: 18436020769167
• NIH Device Record Key: 54dc00ca-2183-4db2-8f02-90837fd390cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOSI-FLOW
• Version Model Number: L2590260-NF-US
• Company DUNS: 461437429
• Company Name: LEVENTON SAU
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08436020769160 [Primary]
GS1	18436020769167 [Package]; Contains: 08436020769160; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851058

FDA Product Code

• LDR: Controller, Infusion, Intravascular, Electronic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-18
• Device Publish Date: 2023-09-08

On-Brand Devices [DOSI-FLOW]

• 18436020764254: I.V. Flow Regulator with Adult Set (20drops/ml) 0.22um Special Filter and Needle Free Injection
• 18436020763462: I.V. Flow Regulator with Adult Set (20drops/ml) 0.22um Special Filter
• 18436020761703: I.V. Flow Regulator with Adult Set (20drops/ml)
• 18436020761369: I.V. Flow Regulator with Adult Set (20drops/ml)
• 18436020760911: I.V. Extension Set with Flow Regulator and Needle Free Injection Site
• 18436020760560: I.V. Flow Regulator with Adult Set (20drops/ml) and Needle Free Injection Site
• 18436020760096: I.V. Extension Set with Flow Regulator
• 08436020769207: I.V. Flow Regulator with Adult Set (20drops/ml)
• 08436020768835: I.V. Flow Regulator with Adult Set (20drops/ml)
• 08436020768828: I.V. Flow Regulator with Pedriatic Set (60drops/ml)
• 18436020769181: Regulator IV Set with Universal Spike (20 drops/mL) with 15 Micron Filter, On/Off Clamp, Flow Re
• 18436020769174: Regulator IV Set with Universal Spike (20 drops/mL) with 15 Micron Filter, On/Off Clamp, Flow Re
• 18436020769167: Regulator Extension Set with Female Luer Connector, Flow Regulator, Needle-Free Injection Site,
• 18436020769150: Regulator Extension Set with Female Luer Connector, Flow Regulator, Injection Site, and Rotating