KNOWme™ 88453

GUDID 00816565020373

KNOWme™ Dried Blood Spot Convenience Kit 2-spot

AMEDITECH INC.

Home blood collection kit IVD

• Primary Device ID: 00816565020373
• NIH Device Record Key: 483e218c-8dc8-439f-8b7a-73852614b9f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KNOWme™
• Version Model Number: 88453
• Catalog Number: 88453
• Company DUNS: 010551716
• Company Name: AMEDITECH INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00816565020373 [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