Disposable Insulin Syringe

GUDID 06949236202021

Berpu Medical Technology Co.,Ltd

Insulin syringe/needle, safety

• Primary Device ID: 06949236202021
• NIH Device Record Key: e1c0e958-0cdd-41b8-92cd-ceeaf48cf3c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Insulin Syringe
• Version Model Number: U-100 1ML 30G×12mm No protective end top
• Company DUNS: 529239746
• Company Name: Berpu Medical Technology Co.,Ltd
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06949236200980 [Primary]
GS1	06949236201505 [Package]; Contains: 06949236200980; Package: [100 Units]; In Commercial Distribution
GS1	06949236202021 [Package]; Contains: 06949236200980; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162180

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: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2017-03-31

On-Brand Devices [Disposable Insulin Syringe]

• 06949236202090: U-100 1ML 31G×8mm Protective end top
• 06949236202083: U-100 1ML 31G×8mm No protective end top
• 06949236202076: U-100 1ML 31G×6mm Protective end top
• 06949236202069: U-100 1ML 31G×6mm No protective end top
• 06949236202052: U-100 1ML 31G×5mm Protective end top
• 06949236202045: U-100 1ML 31G×5mm No protective end top
• 06949236202038: U-100 1ML 30G×12mm Protective end top
• 06949236202021: U-100 1ML 30G×12mm No protective end top
• 06949236202014: U-100 1ML 30G×8mm Protective end top
• 06949236202007: U-100 1ML 30G×8mm No protective end top
• 06949236201994: U-100 1ML 30G×6mm Protective end top
• 06949236201987: U-100 1ML 30G×6mm No protective end top
• 06949236201970: U-100 1ML 29G×12mm Protective end top
• 06949236201963: U-100 1ML 29G×12mm No protective end top
• 06949236201956: U-100 1ML 29G×8mm Protective end top
• 06949236201949: U-100 1ML 29G×8mm No protective end top
• 06949236201932: U-100 1ML 28G×12mm Protective end top
• 06949236201925: U-100 1ML 28G×12mm No protective end top
• 06949236201918: U-100 1ML 27G×12mm Protective end top
• 06949236201901: U-100 1ML 27G×12mm No protective end top
• 06949236201895: U-100 0.5ML 31G×8mm Protective end top
• 06949236201888: U-100 0.5ML 31G×8mm No protective end top
• 06949236201871: U-100 0.5ML 31G×6mm Protective end top
• 06949236201864: U-100 0.5ML 31G×6mm No protective end top
• 06949236201857: U-100 0.5ML 31G×5mm Protective end top
• 06949236201840: U-100 0.5ML 31G×5mm No protective end top
• 06949236201833: U-100 0.5ML 30G×12mm Protective end top
• 06949236201826: U-100 0.5ML 30G×12mm No protective end top
• 06949236201819: U-100 0.5ML 30G×8mm Protective end top
• 06949236201802: U-100 0.5ML 30G×8mm No protective end top
• 06949236201796: U-100 0.5ML 30G×6mm Protective end top
• 06949236201789: U-100 0.5ML 30G×6mm No protective end top
• 06949236201772: U-100 0.5ML 29G×12mm Protective end top
• 06949236201765: U-100 0.5ML 29G×12mm No protective end top
• 06949236201758: U-100 0.5ML 29G×8mm Protective end top
• 06949236201741: U-100 0.5ML 29G×8mm No protective end top
• 06949236201734: U-100 0.5ML 28G×12mm Protective end top
• 06949236201727: U-100 0.5ML 28G×12mm No protective end top
• 06949236201710: U-100 0.3ML 31G×8mm Protective end top
• 06949236201703: U-100 0.3ML 31G×8mm No protective end top
• 06949236201697: U-100 0.3ML 31G×6mm Protective end top
• 06949236201680: U-100 0.3ML 31G×6mm No protective end top
• 06949236201673: U-100 0.3ML 31G×5mm Protective end top
• 06949236201666: U-100 0.3ML 31G×5mm No protective end top
• 06949236201659: U-100 0.3ML 30G×12mm Protective end top
• 06949236201642: U-100 0.3ML 30G×12mm No protective end top
• 06949236201635: U-100 0.3ML 30G×8mm Protective end top
• 06949236201628: U-100 0.3ML 30G×8mm No protective end top
• 06949236201611: U-100 0.3ML 29G×12mm Protective end top
• 06949236201604: U-100 0.3ML 29G×12mm No protective end top