175IBLSSC

GUDID 28053323800020

Catheter Injection port

ELCAM MEDICAL ITALY SPA

Catheter injection port

• Primary Device ID: 28053323800020
• NIH Device Record Key: 137d93aa-4323-424e-9eb6-22cc89522633
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 175IBLSSC
• Version Model Number: 175IBLSSC
• Company DUNS: 513976688
• Company Name: ELCAM MEDICAL ITALY SPA
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08053323800026 [Primary]
GS1	18053323800023 [Package]; Contains: 08053323800026; Package: [100 Units]; In Commercial Distribution
GS1	28053323800020 [Package]; Contains: 18053323800023; Package: [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K855039

FDA Product Code

• GCE: Adaptor, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-27
• Device Publish Date: 2019-02-26

Devices Manufactured by ELCAM MEDICAL ITALY SPA

• 28053323800020 - 175IBLSSC: 2023-07-27Catheter Injection port
• 28053323800020 - 175IBLSSC: 2023-07-27 Catheter Injection port
• 08053323800019 - 07103300/S: 2019-06-07