AccessGUDID - DEVICE: K-Shield Advantage Blood Drawing Kit (00646311630040)

GUDID

Device Identifier (DI) Information

Brand Name: K-Shield Advantage Blood Drawing Kit
Version or Model: BK-64A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BK-64A
Company Name: SB-KAWASUMI LABORATORIES, INC.

Primary DI Number: 00646311630040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690625850 *Terms of Use

Device Description: The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSB	Set, Transfer (Blood/Plasma)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a4cb9d52-d605-47bc-b955-fcb648b8aaf3
Public Version Date: February 28, 2024
Public Version Number: 6
DI Record Publish Date: February 13, 2019