GoodSense Comfort Assist Insulin Syringes

GUDID 10370030128768

1cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct

L PERRIGO COMPANY

Insulin syringe/needle, basic

• Primary Device ID: 10370030128768
• NIH Device Record Key: fe620857-3dc3-4f8e-b796-0a578c0ac79f
• Commercial Distribution Discontinuation: 2018-06-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GoodSense Comfort Assist Insulin Syringes
• Version Model Number: 103108
• Company DUNS: 006013346
• Company Name: L PERRIGO COMPANY
• Device Count: 100
• 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: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370030128761 [Primary]
GS1	10070030510777 [Unit of Use]
GS1	10370030128768 [Package]; Contains: 00370030128761; Package: Shipper [30 Units]; Discontinued: 2018-06-23; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062702

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: 2019-07-11
• Device Publish Date: 2016-09-24

On-Brand Devices [GoodSense Comfort Assist Insulin Syringes]

• 10370030128768: 1cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10370030128751: .5cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
• 10370030128744: .3cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
• 10370030128737: .5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10370030128720: .3cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10370030128713: 1cc 8mm 30G Insulin Syringe, Sterile, Single-Use, 100ct
• 10370030128706: .5cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct
• 10370030128690: .3cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct