Glucertain 30190

GUDID 30856276008827

Glucertain Glucose Cntrol Solution, High, 50/box, 12 boxes/case

CELLERA LLC

Glucose IVD, control

• Primary Device ID: 30856276008827
• NIH Device Record Key: a5bffbf1-eb21-44b9-a8a0-a6eed88384d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucertain
• Version Model Number: 30190
• Catalog Number: 30190
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856276008826 [Primary]
GS1	20856276008820 [Package]; Contains: 00856276008826; Package: box [50 Units]; In Commercial Distribution
GS1	30856276008827 [Package]; Contains: 20856276008820; Package: case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112901

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2018-12-07
• Device Publish Date: 2018-11-06

On-Brand Devices [Glucertain]

• 30856276008827: Glucertain Glucose Cntrol Solution, High, 50/box, 12 boxes/case
• 00856276008819: Glucertain Glucose Control Solution, Low, 50/box, 12 boxes/case
• B492301500: Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
• 00850031608702: Glucose Control Solution, Normal, 50/box, 12 boxes/case
• 00850031608122: Safety Lancet, 28 ga., 100/box, 10 boxes/case
• 00850031608108: Safety Lancet, 26 ga., 100/bx, 10 boxes/case
• 00850005565666: Insulin Safety Syringes 0.5 ml 29 G x 1/2", 100/box, 5 boxes/case
• 00850005565642: Insulin Safety Syringes 1 ml, 29 G x 1/2", 100/box, 5 boxes/case