Tile-T20

Basic Information

• Brand Name: Tile-T20
• Primary DI: 00850038691110
• Version / Model: PN0583-02
• Company Name: Tasso Inc.
• Labeler DUNS: 078431936
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-06
• Public Version: 1
• Public Version Date: 2025-02-14
• Public Version Status: New
• Public Device Record Key: 2b2fa692-0098-4b40-8a4d-4242d4d7fa94

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: 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
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64872	Dried blood spot collection receptacle IVD	A self-contained, pen-like device intended to be used by a healthcare professional at the point-of-care, or by a patient/layperson outside a clinical environment, to collect and contain a dried blood spot specimen for subsequent diagnostic testing or screening. The proximal end includes internal capillary tubes which draw the blood specimen into the device, where it is deposited onto one or multiple dried blood collection paper disc(s). It does not contain needles or a lancet. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850038691117	GS1		60	In Commercial Distribution
Primary	00850038691110	GS1
Package	20850038691114	GS1		20	In Commercial Distribution
Package	30850038691111	GS1		100	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius