Tandem Mobi TruSteel Kit

GUDID 00389152854373

TruSteel, 23"/6mm 10 Pack

Tandem Diabetes Care, Inc.

Ambulatory insulin infusion pump reservoir

• Primary Device ID: 00389152854373
• NIH Device Record Key: ad275f8e-6fd4-45ef-99c9-635b71b2226c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Mobi TruSteel Kit
• Version Model Number: 1018543
• Company DUNS: 827900809
• Company Name: Tandem Diabetes Care, 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389152854373 [Primary]

FDA Product Code

• QFG: Alternate Controller Enabled Insulin Infusion Pump

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: 2025-12-18
• Device Publish Date: 2025-12-10

On-Brand Devices [Tandem Mobi TruSteel Kit]

• 00389152312279: TruSteel, 23"/6mm, 10 pack kit
• 00389152412276: TruSteel, 23"/6mm, 10 pack kit
• 00389152854373: TruSteel, 23"/6mm 10 Pack