BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR AND NEEDLELESS ACCESS CONNECTO

Basic Information

• Brand Name: BLOOD DRAWING KIT WITH ANTINEEDLE STICK PROTECTOR AND NEEDLELESS ACCESS CONNECTO
• Primary DI: 00646311630033
• Version / Model: BK-64A
• Company Name: SB-KAWASUMI LABORATORIES, INC.
• Labeler DUNS: 690625850
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-26
• Public Version: 5
• Public Version Date: 2023-09-06
• Public Version Status: Update
• Public Device Record Key: 1a97c991-660c-4f52-95f6-7a46dbc3c484
• Distribution End Date: 2020-03-20

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: Yes
• 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
KSB	Set, Transfer (Blood/Plasma)	Hematology	864.9875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00646311630033	GS1