Saljet

Basic Information

• Brand Name: Saljet
• Primary DI: 70188151000007
• Version / Model: Saljet 20 HCL
• Company Name: WINCHESTER LABORATORIES LLLP
• Labeler DUNS: 038838914
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2025-01-08
• Public Version: 1
• Public Version Date: 2025-01-16
• Public Version Status: New
• Public Device Record Key: d5ee7070-4f06-4150-9e9d-896b5c91e7e6

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64871	Non-antimicrobial wound irrigation solution, saline	A solution of sodium chloride (NaCl), without additional compounds (i.e., not a multiple solute solution), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and may be supplied in a plastic container with a spray nozzle; it is intended to be used in the home or healthcare facility. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00188151000008	GS1
Primary	70188151000007	GS1
Package	80188151000004	GS1	Case	12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K993969	000