Glucertain 30150

GUDID B492301500

Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case

CELLERA LLC

Glucose IVD, kit, electrometry

• Primary Device ID: B492301500
• NIH Device Record Key: b14a9ce0-c486-4aa6-9771-795b50021862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucertain
• Version Model Number: 30150
• Catalog Number: 30150
• Company DUNS: 960091929
• Company Name: CELLERA LLC
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-892-2391
• Email: sales@cellerallc.com
• Phone: 800-892-2391
• Email: sales@cellerallc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B492301500 [Primary]
HIBCC	B492301501 [Package]; Package: vial [25 Units]; In Commercial Distribution
HIBCC	B492301502 [Package]; Contains: B492301501; Package: box [2 Units]; In Commercial Distribution
HIBCC	B492301503 [Package]; Contains: B492301502; Package: case [260 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112901

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

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: 2018-07-06
• Device Publish Date: 2017-06-07

On-Brand Devices [Glucertain]

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• B492301500: Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
• 00850031608702: Glucose Control Solution, Normal, 50/box, 12 boxes/case
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• 00850031608108: Safety Lancet, 26 ga., 100/bx, 10 boxes/case
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• 00850005565642: Insulin Safety Syringes 1 ml, 29 G x 1/2", 100/box, 5 boxes/case