KNOWme™ 88431

GUDID 00816565020380

KNOWme™ Dried Blood Spot Convenience Kit 4-spot

AMEDITECH INC.

Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Home blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD Capillary blood collection kit IVD

• Primary Device ID: 00816565020380
• NIH Device Record Key: 88181fc0-6620-4dc9-90bc-11a771715acc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KNOWme™
• Version Model Number: 88431
• Catalog Number: 88431
• Company DUNS: 010551716
• Company Name: AMEDITECH INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565020380 [Primary]

FDA Product Code

• OIB: Blood And Urine Collection Kit (Excludes Hiv Testing)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-09
• Device Publish Date: 2023-05-01

On-Brand Devices [KNOWme™]

• 00816565020380: KNOWme™ Dried Blood Spot Convenience Kit 4-spot
• 00816565020373: KNOWme™ Dried Blood Spot Convenience Kit 2-spot
• 00816565020366: KNOWme™ Dried Blood Spot Collection Card