IV Extension Set

GUDID 10369771001263

IV Extension Set

GERI-GENTLE CORPORATION

Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

• Primary Device ID: 10369771001263
• NIH Device Record Key: f5a9791b-41c1-425a-aaa3-a71ee11acbd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Extension Set
• Version Model Number: 11762
• 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: 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	00369771001266 [Primary]
GS1	10369771001263 [Package]; Contains: 00369771001266; Package: Inner [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151151

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2020-02-10
• Device Publish Date: 2019-08-01

Devices Manufactured by GERI-GENTLE CORPORATION

• 00369771003659 - Sharps Collector 5QT: 2023-11-09 Sharps Collector 5QT
• 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