Pen Needle

GUDID 00369771003390

Safety Pen Needle 30G

GERI-GENTLE CORPORATION

Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle

• Primary Device ID: 00369771003390
• NIH Device Record Key: 2867576c-1005-46ea-a9be-c68a923f40e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pen Needle
• Version Model Number: 11-305
• Company DUNS: 361663839
• Company Name: GERI-GENTLE CORPORATION
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00369771003390 [Primary]
GS1	00369771003406 [Package]; Package: inner [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192677

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-11
• Device Publish Date: 2023-09-01

Devices Manufactured by GERI-GENTLE CORPORATION

• 00369771003659 - Sharps Collector 5QT: 2023-11-09 Sharps Collector 5QT
• 00369771003390 - Pen Needle: 2023-09-11Safety Pen Needle 30G
• 00369771003390 - Pen Needle: 2023-09-11 Safety Pen Needle 30G
• 00369771003437 - Prefilled Syrings: 2023-09-11 10ML PREFILLED SYRINGE
• 00369771003161 - Oxygen Concentrator: 2023-08-09 Oxygen Concentrator
• 20369771000782 - Lancets Safety: 2023-08-09 Lancets Safety
• 00369771003123 - SYRINGE RETRACT U100 1cc 29x.5: 2023-07-10 SYRINGE RETRACT U100 1cc 29x.5
• 20369771000898 - Syringes Safety: 2023-02-22 SYR U100 1cc 29x.5
• 20369771000904 - Syringes Safety: 2023-02-22 SYR U100 .5cc 29x.5