HSW SOFT-JECT®

Basic Information

• Brand Name: HSW SOFT-JECT®
• Primary DI: 04035873027461
• Version / Model: 8300005159
• Catalog Number: 8300005159
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 5
• Public Version Date: 2019-11-12
• Public Version Status: Update
• Public Device Record Key: f7af28d9-a740-4c72-a66a-1775f61f4e73
• Distribution End Date: 2019-11-11

Device Description

50 ML (60 ML) HSW SOFT-JECT® LUER LOCK AK 2,00X30/14GX11/4

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
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04035873027454	GS1	CARTON	6	Not in Commercial Distribution	2019-11-11
Primary	04035873027461	GS1
Unit of Use	04035873053132	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

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