HSW SOFT-JECT®

Basic Information

• Brand Name: HSW SOFT-JECT®
• Primary DI: 04035873005421
• Version / Model: 5010.290D0
• Catalog Number: 5010.290D0
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 7000
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 3
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: 66fc014c-b273-40b2-a2e0-22424d485990

Device Description

1 ML HSW SOFT-JECT® TUBERKULIN NON STERILE

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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
Primary	04035873005421	GS1
Unit of Use	00000000000000	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

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