AccessGUDID - DEVICE: SCU Narrow Cap Sampler Syringe Kit (09555240405593)

GUDID

Device Identifier (DI) Information

Brand Name: SCU Narrow Cap Sampler Syringe Kit
Version or Model: A100727
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A100727
Company Name: ITL ASIA PACIFIC SDN. BHD.

Primary DI Number: 09555240405593
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 597723837 *Terms of Use

Device Description: SCU Narrow Cap Sampler Syringe Kit is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For single use only. The device is for use by trained laboratory staff, in a laboratory.

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:	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?
58146	Blood/blood culture specimen transfer spike IVD, manual	A hand-held manual device intended to be used to obtain a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate its transfer to another receptacle [e.g., evacuated blood collection tube] for subsequent analysis. It consists of a spike/needle for sampling the specimen through the sealed stopper of the receptacle (i.e., without opening the receptacle), and is designed to reduce the risk of user exposure to the specimen and spike/needle [e.g., has a plastic housing for guarding the needle]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIB	Device, General Purpose, Microbiology, Diagnostic

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: Yes
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: d026e59b-fa5a-437d-a007-d567e2742c24
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: April 21, 2025