Glucertain 30510

GUDID 00850005565642

Insulin Safety Syringes 1 ml, 29 G x 1/2", 100/box, 5 boxes/case

CELLERA LLC

Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic Insulin syringe/needle, basic

• Primary Device ID: 00850005565642
• NIH Device Record Key: bace3aa7-3df6-4a4a-8cda-04ccf1e7fac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glucertain
• Version Model Number: 30510
• Catalog Number: 30510
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005565635 [Primary]
GS1	00850005565642 [Package]; Contains: 00850005565635; Package: Box [100 Units]; In Commercial Distribution
GS1	10850005565649 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150758

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-09-14

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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
• 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