Orbit®Inserter 700012060

GUDID 07613117022235

Insertion Device for Ypsomed Infusion Sets

Ypsomed AG

Insulin infusion cannula introducer

• Primary Device ID: 07613117022235
• NIH Device Record Key: 0369d3aa-764a-4d6c-809f-129490aa0059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbit®Inserter
• Version Model Number: 700012060
• Catalog Number: 700012060
• Company DUNS: 481742760
• Company Name: Ypsomed AG
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +41344244111
• Email: info@ypsomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613117021979 [Primary]
GS1	07613117022235 [Package]; Contains: 07613117021979; Package: SHIPPER BOX [10 Units]; In Commercial Distribution

FDA Product Code

• KZH: INTRODUCER, SYRINGE NEEDLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-09

Devices Manufactured by Ypsomed AG

• 07613117034795 - Penfine Classic Pen Needles: 2023-06-27 Sterile, single-use, pen needles, 32 Gauge, 4mm (5/32") Length, Extra-thin wall
• 07613117034825 - Penfine Classic Pen Needles: 2023-06-27 Sterile, single-use, pen needles, 31 Gauge, 5mm (3/16") Length, Extra-thin wall
• 07613117034863 - Penfine Classic Pen Needles: 2023-06-27 Sterile, single-use, pen needles, 32 Gauge, 6mm (1/4") Length, Extra-thin wall
• 07613117032326 - Clickfine Pen Needles: 2022-09-02 Sterile, single-use, 6-bevel pen needles, 31 Gauge, 5mm (3/16") Length, Extra-thin wall
• 07613117026196 - Clickfine AutoProtect: 2022-05-05 Sterile, single-use, safety pen needle, 31Gauge, 5mm (3/16”) Length
• 07613117031299 - Clickfine pen needles: 2021-11-09 sterile, single-use, 6-bevel pen needles, 31Gauge, 8mm (5/16") length, extra thin wall
• 07613117017606 - Soft-Release-Micro: 2020-09-23 Soft-Release-Micro Infusion Set, 5.5 mm steel cannula, 30 cm (12") blue tubing. / Infusion set with a steel cannula designed to
• 07613117017613 - Soft-Release-Micro: 2020-09-23 Soft-Release-Micro Infusion Set, 8.5 mm steel cannula, 30 cm (12") blue tubing. / Infusion set with a steel cannula designed to