S-Monovette® POC Collect Kit

Basic Information

• Brand Name: S-Monovette® POC Collect Kit
• Primary DI: 04038917398763
• Version / Model: 51.5100.100
• Catalog Number: 51.5100.100
• Company Name: SARSTEDT, INC.
• Labeler DUNS: 035410179
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-28
• Public Version: 5
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 48cb5df8-add3-4e1b-a48b-7935103ea111
• Distribution End Date: 2022-11-30

Device Description

S-Monovette® POC Collect Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58497	Blood collection set, invasive	A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038917398763	GS1
Package	04038917398756	GS1		50	Not in Commercial Distribution	2022-11-30

Customer Contacts

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