Histoplex

GUDID 00840165401072

Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile.

Pretium Canada Packaging ULC

General tissue specimen container IVD, no additive

• Primary Device ID: 00840165401072
• NIH Device Record Key: 5e02c3e0-fa2b-4742-99a0-d62479ec52ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histoplex
• Version Model Number: H602-FL
• Company DUNS: 246665038
• Company Name: Pretium Canada Packaging ULC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00840165401065 [Unit of Use]
GS1	00840165401072 [Package]; Contains: 10840165401062; Package: [5 Units]; In Commercial Distribution
GS1	10840165401062 [Primary]

FDA Product Code

• NNK: Container, Specimen Mailer And Storage, Non-Sterile

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: 2025-03-12
• Device Publish Date: 2025-03-04

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• 00840165401072 - Histoplex: 2025-03-12 Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile.
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