EXEL Comfort Point Insulin Syringe 26018

GUDID 30020221260183

Insulin Syringe, 0.3cc, 29G X 1/2

Exel International

Insulin syringe/needle, basic

• Primary Device ID: 30020221260183
• NIH Device Record Key: 9a37475e-e647-4407-801c-0931702953b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL Comfort Point Insulin Syringe
• Version Model Number: 26018
• Catalog Number: 26018
• Company DUNS: 180572216
• Company Name: Exel International
• Device Count: 10
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10020221260189 [Unit of Use]
GS1	20020221260186 [Primary]
GS1	30020221260183 [Package]; Contains: 20020221260186; Package: [5 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [EXEL Comfort Point Insulin Syringe]

• 30020221260299: Insulin Syringe, 1cc, 29G X 1/2
• 30020221260282: Insulin Syringe, 0.5cc, 29G X 1/2
• 30020221260275: Insulin Syringe, 1cc, 28G X 1/2
• 30020221260268: Insulin Syringe, 0.5cc, 28G X 1/2
• 30020221260183: Insulin Syringe, 0.3cc, 29G X 1/2
• 30020221260169: Insulin Syringe, 1cc, 30G X 5/16
• 30020221260152: Insulin Syringe, 0.5cc, 30G X 5/16
• 30020221260145: Insulin Syringe, 0.3cc, 30G X 5/16
• 30020221260121: Insulin Syringe, 1cc, 31G X 5/16
• 30020221260114: Insulin Syringe, 0.5cc, 31G X 5/16
• 30020221260107: Insulin Syringe, 0.3cc, 31G X 5/16