AccessGUDID - DEVICE: K-SHIELD PHLEBOTOMY SET WITH ANTINEEDLE STICK PROTECTOR (00646311620010)

GUDID

Device Identifier (DI) Information

Brand Name: K-SHIELD PHLEBOTOMY SET WITH ANTINEEDLE STICK PROTECTOR
Version or Model: BO-1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BO-1000
Company Name: SB-KAWASUMI LABORATORIES, INC.

Primary DI Number: 00646311620010
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 690625850 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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
LHI	Set, I.V. Fluid Transfer

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: c35389f9-0a00-494a-b31f-ac7d40e70b03
Public Version Date: February 02, 2024
Public Version Number: 5
DI Record Publish Date: September 20, 2016