S-Monovette®

Basic Information

• Brand Name: S-Monovette®
• Primary DI: 04038917127677
• Version / Model: 02.1333.001
• Catalog Number: 02.1333.001
• Company Name: Sarstedt Aktiengesellschaft & Co.KG
• Labeler DUNS: 388000270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-09-17
• Public Version: 3
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: f56c139b-0b50-463f-8a63-d69ad64b1e0f

Device Description

S-Monovette® 9ml K2E-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: 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
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47587	Evacuated blood collection tube IVD, anticoagulant/separator	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], 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., testing plasma in molecular diagnostics and viral load detection). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038917127677	GS1
Unit of Use	04038917201377	GS1

Customer Contacts

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