H-Pette with Blade (1000 pieces)

GUDID M52536120

HELENA LABORATORIES CORPORATION

Blood specimen transfer spike IVD

• Primary Device ID: M52536120
• NIH Device Record Key: 8b3869e6-c06a-4956-8e3c-8df2592ec898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-Pette with Blade (1000 pieces)
• Version Model Number: 3612
• Company DUNS: 079396131
• Company Name: HELENA LABORATORIES CORPORATION
• Device Count: 1
• 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: true
• 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

Customer Support Contacts

• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com
• Phone: 1-800-231-5663
• Email: helena@helena.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M52536120 [Primary]

FDA Product Code

• GJG: Pipette, Quantitative, Hematology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-05-26

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• M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit: 2023-09-18
• M52510680010 - SPIFE Touch, CSA 2015 (120V): 2023-09-11