ORAcollect Dx

GUDID 10627595000313

DNA Specimen Collection, Saliva

DNA Genotek Inc

Oral/upper respiratory tract specimen collection swab

• Primary Device ID: 10627595000313
• NIH Device Record Key: 60698651-346b-4865-ae1a-e65ebb8eea59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORAcollect Dx
• Version Model Number: OCD-100A
• Company DUNS: 207983508
• Company Name: DNA Genotek 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: false
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com
• Phone: 1-866-813-6354
• Email: info@dnagenotek.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627595000316 [Primary]
GS1	00627595001009 [Package]; Contains: 00627595000316; Package: OCD-100A.022 [1 Units]; In Commercial Distribution
GS1	00627595001023 [Package]; Contains: 00627595000316; Package: OCD-100A.023 [1 Units]; In Commercial Distribution
GS1	00627595001047 [Package]; Contains: 00627595000316; Package: OCD-100A.024 [1 Units]; In Commercial Distribution
GS1	00627595001061 [Package]; Contains: 00627595000316; Package: OCD-100A.025 [1 Units]; In Commercial Distribution
GS1	10627595000313 [Package]; Contains: 00627595000316; Package: Reclosable Bag [25 Units]; In Commercial Distribution
GS1	10627595001013 [Package]; Contains: 00627595001009; Package: OCD-100A.022+ACP128 [25 Units]; In Commercial Distribution
GS1	10627595001037 [Package]; Contains: 00627595001023; Package: OCD-100A.023+ACP129 [25 Units]; In Commercial Distribution
GS1	10627595001051 [Package]; Contains: 00627595001047; Package: OCD-100A.024+ACP130 [25 Units]; In Commercial Distribution
GS1	10627595001075 [Package]; Contains: 00627595001061; Package: OCD-100A.025+ACP131 [25 Units]; In Commercial Distribution

FDA Product Code

• OYJ: Dna Specimen Collection, Saliva

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: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [ORAcollect Dx]

• 00627595000309: DNA Specimen Collection, Saliva
• 10627595000825: DNA Specimen Collection, Saliva
• 10627595000313: DNA Specimen Collection, Saliva