KNOWme™

Basic Information

• Brand Name: KNOWme™
• Primary DI: 00816565020366
• Version / Model: 88433
• Catalog Number: 88433
• Company Name: AMEDITECH INC.
• Labeler DUNS: 010551716
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-01
• Public Version: 3
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: c6254ac9-178b-4d4a-90b7-70c604401057
• Distribution End Date: 2023-08-25

Device Description

KNOWme™ Dried Blood Spot Collection Card

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
66256	Dried blood spot collection card IVD	A device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient demographic information This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816565020366	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 28 Degrees Celsius