Blood Collection Tube Holders

Basic Information

• Brand Name: Blood Collection Tube Holders
• Primary DI: 00616784693521
• Version / Model: 6935
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2021-05-21
• Public Version: 1
• Public Version Date: 2021-05-31
• Public Version Status: New
• Public Device Record Key: 741cc70d-9bfc-4b96-8fd8-881ce1616d4b

Device Description

Blood Collection Tube Holders with Luer Slip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	864.9125	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37566	Blood collection tube holder, single-use	A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784693538	GS1	Case	4	In Commercial Distribution
Primary	00616784693521	GS1
Unit of Use	00616784693514	GS1