Pasteur Pipette 1 mL

GUDID 17350025914616

Hertart ApS

User-induced pipette

• Primary Device ID: 17350025914616
• NIH Device Record Key: 3a11442c-8a7b-44aa-b1f3-daaee5f7c825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pasteur Pipette 1 mL
• Version Model Number: 16201
• Company DUNS: 305164017
• Company Name: Hertart ApS
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350025914619 [Primary]
GS1	17350025914616 [Package]; Contains: 07350025914619; Package: [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201213

FDA Product Code

• MQK: Labware, Assisted Reproduction

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: 2020-12-30
• Device Publish Date: 2020-12-22

Devices Manufactured by Hertart ApS

• 17350025914579 - Sample Tube 5 mL: 2021-06-14
• 17350025914562 - Sperm Collection Container: 2021-05-10
• 17350025914616 - Pasteur Pipette 1 mL: 2020-12-30
• 17350025914616 - Pasteur Pipette 1 mL: 2020-12-30
• 17350025914623 - Pasteur Pipette 3 mL: 2020-12-30
• 07350025914541 - Collection Dish 90 mm: 2020-06-08
• 07350025914558 - Oocyte Collection Tube 14 mL: 2020-06-08
• 27350025914590 - Centrifuge Tube 15 mL: 2020-06-08
• 27350025914606 - Centrifuge Tube 50 mL: 2020-06-08