Tube 4 ml, 75 x 12 mm, K3E

Basic Information

• Brand Name: Tube 4 ml, 75 x 12 mm, K3E
• Primary DI: 04066916016494
• Version / Model: 36.338.101
• Company Name: Sarstedt Aktiengesellschaft & Co.KG
• Labeler DUNS: 388000270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-12-04
• Public Version: 1
• Public Version Date: 2024-12-12
• Public Version Status: New
• Public Device Record Key: f90921c0-2f5b-40ff-89c1-c309d5692e2e

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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58144	Non-evacuated blood collection tube IVD, anticoagulant	A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), lithium heparin, sodium citrate]. 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 lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening, plasma coagulation studies and/or and quantitative drug assay 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	04066916016487	GS1
Primary	04066916016494	GS1