AccessGUDID - DEVICE: K-SHIELD ADVANTAGE SMALL VEIN INFUSION SET (00646311410475)

GUDID

Device Identifier (DI) Information

Brand Name: K-SHIELD ADVANTAGE SMALL VEIN INFUSION SET
Version or Model: D3KA-23G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D3KA-23G
Company Name: SB-KAWASUMI LABORATORIES, INC.

Primary DI Number: 00646311410475
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690625850 *Terms of Use

Device Description: The K-Shield Advantage Small Vein Infusion Set with Antineedle Stick Protector is used to access a patient's vein for solution infusion. 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?
65416	Basic intravenous administration set, invasive	A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. 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: 8b57455e-26ab-43f2-9f01-84e9fb29c0e3
Public Version Date: January 30, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2016