DOSI-FUSER

GUDID 18436020760010

Elastomeric Infusion Pump

LEVENTON SAU

Elastomeric infusion pump system

• Primary Device ID: 18436020760010
• NIH Device Record Key: b60b7b20-d937-46cb-a280-7bc6f4c9c61c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOSI-FUSER
• Version Model Number: L25915-250D7-USA
• 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

Device Dimensions

• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter
• Total Volume: 250 Milliliter

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	08436020760013 [Primary]
GS1	18436020760010 [Package]; Contains: 08436020760013; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040752

FDA Product Code

• MEB: Pump, Infusion, Elastomeric

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: 2022-11-29
• Device Publish Date: 2016-08-24

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• 18436020767477: Elastomeric Infusion Pump
• 18436020764858: Elastomeric Infusion Pump
• 18436020763882: Elastomeric Infusion Pump
• 08436020763878: Elastomeric Infusion Pump
• 08436020763861: Elastomeric Infusion Pump
• 18436020762175: Elastomeric Infusion Pump
• 18436020762106: Elastomeric Infusion Pump
• 18436020762038: Elastomeric Infusion Pump
• 18436020761895: Elastomeric Infusion Pump
• 18436020761864: Elastomeric Infusion Pump
• 18436020760089: Elastomeric Infusion Pump
• 18436020760065: Elastomeric Infusion Pump
• 18436020760058: Elastomeric Infusion Pump
• 18436020760027: Elastomeric Infusion Pump
• 18436020760010: Elastomeric Infusion Pump