Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT

GUDID B2086345633

Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT MARKING

GLOBAL DIABETIC DISTRIBUTORS INC

Insulin syringe/needle, basic

• Primary Device ID: B2086345633
• NIH Device Record Key: f9673cd7-7dee-4a39-8adc-873c08ecf012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT
• Version Model Number: 634563
• Company DUNS: 796779283
• Company Name: GLOBAL DIABETIC DISTRIBUTORS 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2086345630 [Primary]
HIBCC	B2086345631 [Package]; Contains: B2086345630; Package: 100 [100 Units]; In Commercial Distribution
HIBCC	B2086345632 [Package]; Contains: B2086345631; Package: Inner Case [5 Units]; In Commercial Distribution
HIBCC	B2086345633 [Package]; Contains: B2086345632; Package: Shipping Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110421

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by GLOBAL DIABETIC DISTRIBUTORS INC

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• B2086710203 - Easy Glide 10cc Luer Lock Syringe: 2018-09-12 Easy Glide 10cc Luer Lock Syringe
• B2086713503 - Easy Glide 1cc Luer Lock Syringe: 2018-09-12 Easy Glide 1cc Luer Lock Syringe
• B2086760603 - Easy Glide 60cc Cath Tip Syringe: 2018-09-12 Easy Glide 60cc Cath Tip Syringe
• B2086766600 - Easy Glide 60cc Luer Lock Syringe: 2018-09-12 Easy Glide 60cc Luer Lock Syringe
• B2086295013 - Easy Glide INSULIN SYRINGE 1 ML 29GX1/2": 2018-07-06 Easy Glide INSULIN SYRINGE 1 ML 29GX1/2"