Insulin Syringe

GUDID 00616784694931

DYNAREX CORPORATION

Insulin syringe/needle, basic

• Primary Device ID: 00616784694931
• NIH Device Record Key: e82e8cbe-8f94-4c6a-867d-6457e48f1c06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insulin Syringe
• Version Model Number: 6949
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784694917 [Unit of Use]
GS1	00616784694924 [Primary]
GS1	00616784694931 [Package]; Contains: 00616784694924; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112057

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: 2016-09-24

On-Brand Devices [Insulin Syringe]

• 00616784695938: 6959
• 00616784695839: 6958
• 00616784695730: 6957
• 00616784695631: 6956
• 00616784695532: 6955
• 00616784695433: 6954
• 00616784695334: 6953
• 00616784695235: 6952
• 00616784695136: 6951
• 00616784695037: 6950
• 00616784694931: 6949
• 00616784694832: 6948
• 00616784694733: 6947
• 00616784694634: 6946
• 00616784694535: 6945
• 00616784694436: 6944
• 00616784694337: 6943
• 00616784694238: 6942
• 00616784694139: 6941
• 00616784694030: 6940