S-Monovette®

Basic Information

• Brand Name: S-Monovette®
• Primary DI: 04038917797573
• Version / Model: 06.1669.200
• Catalog Number: 06.1669.200
• Company Name: Sarstedt Aktiengesellschaft & Co.KG
• Labeler DUNS: 388000270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-07-19
• Public Version: 1
• Public Version Date: 2022-07-27
• Public Version Status: New
• Public Device Record Key: 820189c3-031e-4408-8161-cdec18eece07

Device Description

S-Monovette® 1.1ml LH-Gel

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: Yes
• 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
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58145	Non-evacuated blood collection tube IVD, anticoagulant/separator	A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., lithium heparin, ethylenediaminetetraacetic acid (EDTA)] and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04038917797542	GS1
Primary	04038917797573	GS1

Customer Contacts

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