Temena

Basic Information

• Brand Name: Temena
• Primary DI: 03700339711970
• Version / Model: 900LS-10
• Catalog Number: 900LS-10
• Company Name: Temena GmbH
• Labeler DUNS: 329515725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-28
• Public Version: 3
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: e89a3b5e-ce6c-41c2-b6f9-b31d2fb7e8ca

Device Description

LOR syringe Polypropylene Luer Slip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44884	Low-resistance epidural syringe	A low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03700339701971	GS1	box	10	In Commercial Distribution
Primary	03700339711970	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter