Safety SubCulture Unit 2 (SCU2)

Basic Information

• Brand Name: Safety SubCulture Unit 2 (SCU2)
• Primary DI: 19555240401431
• Version / Model: A100722
• Catalog Number: A100722
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Labeler DUNS: 597723837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-19
• Public Version: 2
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 51638717-4abe-4a00-b32d-3b8d04c331e5

Device Description

SCU2 is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58146	Blood/blood culture specimen transfer spike IVD	A blood or blood culture specimen transfer device intended to be used to obtain for analysis a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate specimen transfer to another receptacle [e.g., evacuated blood collection tube]. It is a hand-held, manually-operated device with 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	19555240401448	GS1	Inner Box	48	In Commercial Distribution
Primary	19555240401431	GS1
Package	19555240401455	GS1	Carton	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Direct Sunlight