Advocate Sleeve of 10 Syringes 31G .3CC 613

GUDID 10894046001728

Advocate Sleeve of 10 Syringes 31G .3CC

DIABETIC SUPPLY OF SUNCOAST, INC.

Metered-delivery hypodermic syringe

• Primary Device ID: 10894046001728
• NIH Device Record Key: 5ee9a18d-8c49-45a9-b312-ac666a1c68f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advocate Sleeve of 10 Syringes 31G .3CC
• Version Model Number: 613
• Catalog Number: 613
• Company DUNS: 043081723
• Company Name: DIABETIC SUPPLY OF SUNCOAST, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: true

Customer Support Contacts

• Phone: 1-866-373-2824
• Email: skolta@dsosi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894046001721 [Package]; Contains: 00894046001820; Package: 614 [10 Units]; In Commercial Distribution
GS1	00894046001820 [Primary]
GS1	10894046001728 [Package]; Contains: 00894046001820; Package: 631 [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162180

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2016-08-20

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