CDC - Premier Value - 31Gx5mm pen needles w/remover AN 3850CDC

GUDID 00840986029387

For use with injectors for the subcutaneous injection of approved drugs, including insulin

PHARMACY VALUE ALLIANCE, LLC

Autoinjector needle

• Primary Device ID: 00840986029387
• NIH Device Record Key: 3d8d40a0-b6d7-4789-9498-c81778064a50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDC - Premier Value - 31Gx5mm pen needles w/remover
• Version Model Number: AN 3850CDC
• Catalog Number: AN 3850CDC
• Company DUNS: 089138159
• Company Name: PHARMACY VALUE ALLIANCE, LLC
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 435 649-7251
• Email: xx@xx.xx

Device Dimensions

• Needle Gauge: 31 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703850009 [Unit of Use]
GS1	00761059851288 [Package]; Package: Sleeve [6 Units]; In Commercial Distribution
GS1	00761059852285 [Package]; Contains: 00761059851288; Package: Case [24 Units]; In Commercial Distribution
GS1	00840986029387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152339

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2016-09-19

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