Saljet

GUDID 60188151000000

Saljet is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into a shelf carton. Twenty vials per carton.

WINCHESTER LABORATORIES LLLP

Non-antimicrobial wound irrigation solution, saline

• Primary Device ID: 60188151000000
• NIH Device Record Key: 42ea0947-9fd0-4716-ae16-b780b7cfc639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saljet
• Version Model Number: Saljet 20
• Company DUNS: 038838914
• Company Name: WINCHESTER LABORATORIES LLLP
• Device Count: 20
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00188151000015 [Unit of Use]
GS1	50188151000003 [Primary]
GS1	60188151000000 [Package]; Contains: 50188151000003; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993969

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2024-07-15
• Device Publish Date: 2024-07-05