SampLok® System with Hinged Lid

Basic Information

• Brand Name: SampLok® System with Hinged Lid
• Primary DI: 19555240401158
• Version / Model: A100645
• Catalog Number: A100645
• 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: 2019-03-29
• Public Version: 1
• Public Version Date: 2019-04-08
• Public Version Status: New
• Public Device Record Key: b1c619af-4e42-46bc-98be-716284af33cc

Device Description

SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests

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: No
• 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
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	2
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58284	Blood collection tube holder/needle	A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	19555240400007	GS1	Carton	425	In Commercial Distribution
Primary	19555240401158	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021941	000

Storage Conditions

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