Sample Collection Tubes

Basic Information

• Brand Name: Sample Collection Tubes
• Primary DI: 05056080501659
• Version / Model: R30853001
• Company Name: REMEL EUROPE LIMITED
• Labeler DUNS: 232600853
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-21
• Public Version: 2
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 6fb9f565-d948-45bc-b40f-035a6df3b8d7

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
47590	Evacuated blood collection tube IVD, no additive	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum with no additive. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum chemistry determinations including trace elements, serology, and toxicology). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056080501659	GS1

Customer Contacts

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