HSW HENKE-JECT®

Basic Information

• Brand Name: HSW HENKE-JECT®
• Primary DI: 04035873059745
• Version / Model: 4850002000
• Catalog Number: 4850002000
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 1
• Public Version Date: 2020-12-17
• Public Version Status: New
• Public Device Record Key: 4dd42906-4cbb-4e58-a887-4762e34e03ea

Device Description

HSW HENKE-JECT® 2-TLG. 50 ML (60 ML) 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	04035873059752	GS1	CARTON	10	In Commercial Distribution
Primary	04035873059745	GS1
Unit of Use	04035873059738	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: PROTECT FROM SUNLIGHT,KEEP DRY