The Inseminator

GUDID 20888937011474

Intrauterine Inseminator 3.5 FR 5.5" Long with Syringe

Coopersurgical, Inc.

Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set

• Primary Device ID: 20888937011474
• NIH Device Record Key: 16e1f324-5af9-460b-823c-2e48ae2ed087
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Inseminator
• Version Model Number: 920012
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: false
• 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

• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937011470 [Primary]
GS1	20888937011474 [Package]; Contains: 00888937011470; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984306

FDA Product Code

• MFD: Cannula, Intrauterine Insemination

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: 2019-01-23
• Device Publish Date: 2016-08-25

On-Brand Devices [The Inseminator]

• 00888937011494: Intrauterine Inseminator, 3.5 French, 4.5" Long, without Syringe
• 20888937011481: Intrauterine Inseminator, 3.5 French, 4.5" Long, with Syringe
• 20888937011474: Intrauterine Inseminator 3.5 FR 5.5" Long with Syringe