Sure Comfort 22-6504

GUDID 00786227650494

0.3mL 31G 8mm Single use disposable insulin syringe with needle and half unit measure. Includes 100 sterile syringes in convenient 10 pack bags.

ALLISON MEDICAL, INC.

Insulin syringe/needle, basic

• Primary Device ID: 00786227650494
• NIH Device Record Key: 3187f421-6d5c-48f9-886a-3272c6e2a8eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure Comfort
• Version Model Number: 22-6504
• Catalog Number: 22-6504
• Company DUNS: 825097264
• Company Name: ALLISON MEDICAL, INC.
• Device Count: 100
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-886-1618
• Email: info@allisonmedical.com
• Phone: 1-800-886-1618
• Email: info@allisonmedical.com

Device Dimensions

• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00786227650432 [Unit of Use]
GS1	00786227650456 [Primary]
GS1	00786227650470 [Package]; Contains: 00786227650456; Package: Case [5 Units]; In Commercial Distribution
GS1	00786227650494 [Package]; Contains: 00786227650470; Package: Master Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152879

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: 2016-11-03

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