S-Monovette®

Basic Information

• Brand Name: S-Monovette®
• Primary DI: 04038917228305
• Version / Model: 01.1624.001
• Catalog Number: 01.1624.001
• Company Name: SARSTEDT, INC.
• Labeler DUNS: 035410179
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2020-04-01
• Public Version Status: Update
• Public Device Record Key: df29c612-448d-4bb4-90ba-383e3f1bcea9

Device Description

S-Monovette® 8.8 ml ACD-A

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

GMDN Terms

Code	Name	Definition	Implantable	Status
42583	Evacuated blood collection tube IVD, acid citrate dextrose A (ACD-A)	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood anticoagulant acid citrate dextrose A (ACD-A). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood grouping, human leukocyte antigen (HLA) phenotyping and deoxyribonucleic acid (DNA) testing]. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04038917228299	GS1		500	In Commercial Distribution
Primary	04038917228305	GS1
Unit of Use	04038917228312	GS1

Customer Contacts

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