Rapid fFN 71738-001

GUDID 15420045514768

FFN SPECIMEN COLLECTION KIT, 25PK

Hologic, Inc.

Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical Urogenital specimen collection kit IVD, clinical

• Primary Device ID: 15420045514768
• NIH Device Record Key: 5e91b08b-dd34-421e-a3ec-f18bff30947e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid fFN
• Version Model Number: FFN SPECIMEN COLLECTION KIT, 25PK
• Catalog Number: 71738-001
• Company DUNS: 050579217
• Company Name: Hologic, Inc.
• Device Count: 25
• DM Exempt: true
• 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: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045514768 [Unit of Use]
GS1	25420045514765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900225

FDA Product Code

• LIO: Device, specimen collection

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: 2022-11-23
• Device Publish Date: 2022-11-15

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