AccessGUDID - DEVICE: IV Start Kit (09555240405210)

GUDID

Device Identifier (DI) Information

Brand Name: IV Start Kit
Version or Model: IVSK100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IVSK100
Company Name: ITL ASIA PACIFIC SDN. BHD.

Primary DI Number: 09555240405210
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 597723837 *Terms of Use

Device Description: IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The procedure packs are widely used by clinical professionals using aseptic technique for patient requires Intravenous Cannula Insertion.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
33963	Peripheral intravenous catheterization support kit	A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LRS	I.V. Start Kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away from Direct Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11ecdc68-e83e-4d22-90ad-1fc9d9d09286
Public Version Date: July 14, 2023
Public Version Number: 2
DI Record Publish Date: June 28, 2023