KNOWme™

Basic Information

• Brand Name: KNOWme™
• Primary DI: 00816565020380
• Version / Model: 88431
• Catalog Number: 88431
• 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: 4
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: 88181fc0-6620-4dc9-90bc-11a771715acc
• Distribution End Date: 2023-08-25

Device Description

KNOWme™ Dried Blood Spot Convenience Kit 4-spot

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: 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
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	864.3250	1

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	00816565020380	GS1

Storage Conditions

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