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 Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive 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