HSW SOFT-JECT®

Basic Information

• Brand Name: HSW SOFT-JECT®
• Primary DI: 04035873027621
• Version / Model: 8300005458
• Catalog Number: 8300005458
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2019-11-22
• Public Version Status: Update
• Public Device Record Key: e0d7d1fa-c269-42ca-b047-9bf8e7a39a20
• Distribution End Date: 2019-11-21

Device Description

100 ML (120ML) HSW SOFT-JECT®KATHETER

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04035873027614	GS1	CARTON	6	Not in Commercial Distribution	2019-11-21
Primary	04035873027621	GS1
Unit of Use	04035873053156	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry