Ultra-Care Pen Needles 31G 3/16" 100 Ct

GUDID 00372217006022

Insulin Pen Needle

ARISE MEDICAL LLC

Autoinjector needle

• Primary Device ID: 00372217006022
• NIH Device Record Key: c80bbf14-120a-45d3-84aa-a7a09e7705c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-Care Pen Needles 31G 3/16" 100 Ct
• Version Model Number: 240394
• Company DUNS: 081149273
• Company Name: ARISE MEDICAL LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372217006022 [Primary]
GS1	00372217006275 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	00372217006527 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133059

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: 2020-01-20
• Device Publish Date: 2018-11-29

Devices Manufactured by ARISE MEDICAL LLC

• 00372217036081 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - M- 100 Ct
• 00372217036098 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - L- 100 Ct
• 00372217036104 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - XL- 100 Ct
• 00372217036319 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - XS- 100 Ct
• 00372217036326 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - S- 100 Ct
• 00372217004035 - Procare Basic Upper Arm BP Monitor: 2020-08-31 Upparm Arm blood pressure monitor with standard cuff
• 00372217004042 - Procare Upper Arm BP Monitor with XL Cuff: 2020-08-31 Procare Upper Arm BP Monitor with XL Cuff
• 00372217005094 - Safari Express Pediatric Nebulizer: 2020-08-31 Safari Express Pediatric Nebulizer