Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ 1001215

GUDID 10020221012153

Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ 100/BX, 1000/CS

Exel International

General-purpose syringe/needle

• Primary Device ID: 10020221012153
• NIH Device Record Key: 4459c222-da51-4e38-ab78-95d81d870dfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tandem Diabetes 3mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’
• Version Model Number: 1001215
• Catalog Number: 1001215
• Company DUNS: 180572216
• Company Name: Exel International
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221012156 [Primary]
GS1	10020221012153 [Package]; Contains: 00020221012156; Package: Inner box [100 Units]; In Commercial Distribution
GS1	20020221012150 [Package]; Package: Case [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861153

FDA Product Code

• FMF: Syringe, Piston

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: 2023-04-25
• Device Publish Date: 2023-04-17

Devices Manufactured by Exel International

• 20020221260032 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 29G x 1/2
• 20020221260049 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/4
• 20020221260056 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/3
• 20020221260063 - EXEL Comfort Point Insulin Pen Needles: 2024-06-26 Insulin Pen Needle, 31G x 1/6
• 10020221277644 - Exel SecureTouch Safety Blood Collection Set: 2024-03-19 Safety Scalp Vein Set/Multi-Sample Luer Adapter, 21G X 3/4, 12" tube
• 00020221277661 - Exel SecureTouch Safety Blood Collection Set: 2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 23G X 3/4, 12" tube
• 00020221277685 - Exel SecureTouch Safety Blood Collection Set: 2024-03-15 Safety Scalp Vein Set/ Multi-Sample Luer Adapter, 25G X 3/4, 12" tube
• 10020221017127 - Advance Plus Universal IV Administration Set: 2023-11-08 IV Administration Set, Luer Lock/Slip, 12" tubing