Zinzino

Basic Information

• Brand Name: Zinzino
• Primary DI: 04779054720122
• Version / Model: BT1
• Company Name: RDA SPOT, UAB
• Labeler DUNS: 681642418
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-27
• Public Version: 1
• Public Version Date: 2025-01-06
• Public Version Status: New
• Public Device Record Key: f2c31a6d-5387-40d1-a6aa-e02764ccceb4

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• 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
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65433	Capillary blood collection kit IVD	A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04779054720122	GS1