Biotronix Healthcare Insulin Pen Needles

GUDID 20858835007985

Insulin Pen Needle 31G x 3/16"(5mm), Each

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Autoinjector needle

• Primary Device ID: 20858835007985
• NIH Device Record Key: a472ebe2-c0cd-463c-bc8d-3ad240a35e31
• Commercial Distribution Discontinuation: 2030-02-28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronix Healthcare Insulin Pen Needles
• Version Model Number: GE44004
• Company DUNS: 065762392
• Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 786-473-9436
• Email: MBORGES@BIOTRONIXHEALTHCARE.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858835007981 [Primary]
GS1	10858835007988 [Package]; Contains: 00858835007981; Package: INNER BOX [100 Units]; Discontinued: 2028-08-31; In Commercial Distribution
GS1	20858835007985 [Package]; Contains: 10858835007988; Package: CASE [8 Units]; Discontinued: 2028-08-31; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133058

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-09-29

Devices Manufactured by BIOTRONIX HEALTHCARE INDUSTRIES, INC.

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