Smart Sense Insulin Syringes

GUDID 10883967398161

.3cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct

KMART HOLDING CORPORATION

Insulin syringe/needle, basic

• Primary Device ID: 10883967398161
• NIH Device Record Key: f5e32fbb-2777-440a-a650-2fdee1170f8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Sense Insulin Syringes
• Version Model Number: 033108
• Company DUNS: 131978533
• Company Name: KMART HOLDING CORPORATION
• 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

• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883967398164 [Primary]
GS1	10070030510722 [Unit of Use]
GS1	10883967398161 [Package]; Contains: 00883967398164; Package: Shipper [30 Units]; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Smart Sense Insulin Syringes]

• 10883967398185: 1cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10883967398178: .5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10883967398161: .3cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct
• 10883967398154: 1cc 12.7mm 29G Insulin Syringe, Sterile, Single-Use, 100ct
• 10883967398147: .5cc 12.7mm 29G Insulin Syringe, Sterile, Single Use, 100ct