Smart Sense Pen Needles

GUDID 10883967398123

Sterile, Single-Use, 6-bevel pen needles, 31 Gauge, 6mm (1/4") Length

KMART HOLDING CORPORATION

Autoinjector needle

• Primary Device ID: 10883967398123
• NIH Device Record Key: 163ca06f-80ee-456e-9ebe-6863340c09ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Sense Pen Needles
• Version Model Number: 700001337
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Needle Gauge: 31 Gauge
• Needle Gauge: 31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883967398126 [Primary]
GS1	10883967398123 [Package]; Contains: 00883967398126; Package: Shipper [20 Units]; In Commercial Distribution
GS1	30883967398127 [Unit of Use]

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Smart Sense Pen Needles]

• 10883967398130: Sterile, Single-Use, 6-bevel pen needles, 31 Gauge, 8mm (5/16") Length
• 10883967398123: Sterile, Single-Use, 6-bevel pen needles, 31 Gauge, 6mm (1/4") Length