CDMA Quality Choice - 4mm pen needles AN 3540QC

GUDID 00635515969438

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

CHAIN DRUG MARKETING ASSOCIATION, INC.

Autoinjector needle

• Primary Device ID: 00635515969438
• NIH Device Record Key: a4629fe8-b5cf-4712-9ec4-747f7bd42b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDMA Quality Choice - 4mm pen needles
• Version Model Number: AN 3540QC
• Catalog Number: AN 3540QC
• Company DUNS: 011920774
• Company Name: CHAIN DRUG MARKETING ASSOCIATION, 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 248-449-9300
• Email: xx@xx.xx
• Phone: 248-449-9300
• Email: xx@xx.xx

Device Dimensions

• Length: 4 Millimeter
• Length: 4 Millimeter
• Length: 4 Millimeter
• Length: 4 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384703540009 [Unit of Use]
GS1	00635515969438 [Primary]
GS1	00761059541332 [Package]; Package: Sleeve [10 Units]; In Commercial Distribution
GS1	00761059542339 [Package]; Contains: 00761059541332; Package: Case [50 Units]; In Commercial Distribution

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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