Procare Pen Needles 33G 1/4"

GUDID 00372217006121

ARISE MEDICAL LLC

Autoinjector needle

• Primary Device ID: 00372217006121
• NIH Device Record Key: 479da73c-4f28-4578-900d-0fab336a04cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procare Pen Needles 33G 1/4"
• Version Model Number: 240528
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372217006121 [Primary]
GS1	00372217006626 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133058

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-16
• Device Publish Date: 2019-09-07

Devices Manufactured by ARISE MEDICAL LLC

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• 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