Easy Glide INSULIN SYRIN 0.3 ML 31GX5/16"

GUDID B2086315633

Easy Glide INSULIN SYRIN 0.3 ML 31GX5/16"

GLOBAL DIABETIC DISTRIBUTORS INC

Insulin syringe/needle, basic

• Primary Device ID: B2086315633
• NIH Device Record Key: ee957bc6-bfab-48f8-98e3-909ef250b8ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Glide INSULIN SYRIN 0.3 ML 31GX5/16"
• Version Model Number: 631563
• 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	B2086315630 [Primary]
HIBCC	B2086315631 [Package]; Contains: B2086315630; Package: Box [100 Units]; In Commercial Distribution
HIBCC	B2086315632 [Package]; Contains: B2086315631; Package: Inner Case [5 Units]; In Commercial Distribution
HIBCC	B2086315633 [Package]; Contains: B2086315632; 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

• B2086720203 - Easy Glide 20cc Luer Lock Syringe: 2019-09-30 Easy Glide 20cc Luer Lock Syringe
• B2086733303 - Easy Glide 30cc Luer Lock Syringe: 2019-05-07 Easy Glide 30cc Luer Lock Syringe
• B2086730303 - Easy Glide 3cc Luer Lock Syringe: 2019-04-17 Easy Glide 3cc Luer Lock Syringe
• 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"