S-Monovette®

Basic Information

• Brand Name: S-Monovette®
• Primary DI: 04038917522830
• Version / Model: 04.1952.100
• Catalog Number: 04.1952.100
• Company Name: Sarstedt Aktiengesellschaft & Co.KG
• Labeler DUNS: 388000270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-09-24
• Public Version: 3
• Public Version Date: 2023-09-05
• Public Version Status: Update
• Public Device Record Key: d7bbb216-19a6-40e1-81c0-8af41c7f8621

Device Description

S-Monovette® 2.7ml 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
Primary	04038917522830	GS1
Unit of Use	04038917522847	GS1

Customer Contacts

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