DOSI-PAIN

GUDID 18436020766654

Elastomeric Infusion Pump

LEVENTON SAU

Elastomeric infusion pump system

• Primary Device ID: 18436020766654
• NIH Device Record Key: 06fd5a3b-72e3-4e55-9dd8-94e3d9ec2344
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DOSI-PAIN
• Version Model Number: L25915-250D1x2-SM
• 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	08436020766657 [Primary]
GS1	18436020766654 [Package]; Contains: 08436020766657; Package: Box [10 Units]; Discontinued: 2018-12-31; Not 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: 2
• Public Version Date: 2022-11-29
• Device Publish Date: 2018-12-31

On-Brand Devices [DOSI-PAIN]

• 18436020766814: Elastomeric Infusion Pump
• 18436020766807: Elastomeric Infusion Pump
• 18436020766791: Elastomeric Infusion Pump
• 18436020766654: Elastomeric Infusion Pump
• 18436020766647: Elastomeric Infusion Pump
• 18436020766630: Elastomeric Infusion Pump
• 18436020766623: Elastomeric Infusion Pump
• 18436020766494: Elastomeric Infusion Pump
• 18436020766487: Elastomeric Infusion Pump
• 18436020766470: Elastomeric Infusion Pump
• 18436020766463: Elastomeric Infusion Pump
• 18436020766456: Elastomeric Infusion Pump
• 18436020766449: Elastomeric Infusion Pump
• 18436020766432: Elastomeric Infusion Pump
• 18436020766425: Elastomeric Infusion Pump
• 18436020766418: Elastomeric Infusion Pump
• 18436020766401: Elastomeric Infusion Pump