ACT II Transport PK/10

GUDID 00842558116426

REMEL, INC.

General specimen collection kit IVD, clinical

• Primary Device ID: 00842558116426
• NIH Device Record Key: f515b484-a6a7-4bbd-a181-e96f1543eff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACT II Transport PK/10
• Version Model Number: R124101
• Company DUNS: 065769564
• Company Name: REMEL, 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842558116426 [Primary]

FDA Product Code

• JSL: Culture Media, Anaerobic Transport

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: 2024-08-14
• Device Publish Date: 2024-08-06

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