BacT/ALERT® Blood Collection Adapter Insert

GUDID 03573026125769

The Adapter Insert is used with The BacT/ALERT Blood Collection Adapter. It can be locked inside the Adapter Cap to allow blood to be filled into vacuum collection tubes.

BIOMERIEUX , INC.

Blood collection tube holder, reusable

• Primary Device ID: 03573026125769
• NIH Device Record Key: a44a7cae-5160-41ca-8b4e-25663091ba72
• Commercial Distribution Discontinuation: 2021-02-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BacT/ALERT® Blood Collection Adapter Insert
• Version Model Number: BacT/ALERT® Blood Collection Adapter Insert
• Company DUNS: 086785110
• Company Name: BIOMERIEUX , INC.
• Device Count: 60
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026125769 [Package]; Contains: 03573026556129; Package: [1 Units]; Discontinued: 2021-02-26; Not in Commercial Distribution
GS1	03573026556112 [Unit of Use]
GS1	03573026556129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933939

FDA Product Code

• GIM: Tubes, Vacuum Sample, With Anticoagulant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-03-23
• Device Publish Date: 2016-12-14

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