AccessGUDID - DEVICE: K-SHIELD ADVANTAGE WINGED BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER (04987488103477)

GUDID

Device Identifier (DI) Information

Brand Name: K-SHIELD ADVANTAGE WINGED BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Version or Model: DBMH-23G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DBMH-23G
Company Name: SB-KAWASUMI LABORATORIES, INC.

Primary DI Number: 04987488103477
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690625850 *Terms of Use
Previous DI: 00646311400278

Device Description: The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached Holder is used to access a patient's vein for blood sampling. The device incorporates an integral, active antineedle stick protector.

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

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
Needle Gauge: 23 Gauge

Device Record Status

Public Device Record Key: 3f8ece08-a62f-4819-9063-3a431372632b
Public Version Date: April 10, 2024
Public Version Number: 1
DI Record Publish Date: April 02, 2024