NIPRO INSULIN SYRINGE JD+01U3108-SB

GUDID 40383790002248

NIPRO MEDICAL CORPORATION

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• Primary Device ID: 40383790002248
• NIH Device Record Key: 04aff705-dd62-48c3-b4a3-ba5edf16b8cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIPRO INSULIN SYRINGE
• Version Model Number: JD+01U3108-SB
• Catalog Number: JD+01U3108-SB
• Company DUNS: 797372554
• Company Name: NIPRO MEDICAL CORPORATION
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com
• Phone: 908-393-7030
• Email: info@nipromed.com

Device Dimensions

• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 31 Gauge
• Length: 0.3125 Inch
• Total Volume: 1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790002240 [Primary]
GS1	10383790002247 [Package]; Contains: 00383790002240; Package: BOX [100 Units]; In Commercial Distribution
GS1	40383790002248 [Package]; Contains: 10383790002247; Package: CASE [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112057

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: 2
• Public Version Date: 2018-07-25
• Device Publish Date: 2018-06-12

On-Brand Devices [NIPRO INSULIN SYRINGE]

• 40383790008790: JD+01U2913-SB
• 40383790008783: JD+01U3008-SB
• 40383790008776: JD+01U3013-SB
• 40383790002248: JD+01U3108-SB