LMP

GUDID 01850062218313

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.

Promisemed Medical Devices Inc.

Insulin syringe/needle, basic

• Primary Device ID: 01850062218313
• NIH Device Record Key: 0108391b-ffb8-4d38-b5f7-4f8110fe58ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMP
• Version Model Number: MIS-102912-100
• Company DUNS: 114566189
• Company Name: Promisemed Medical Devices Inc.
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850062218314 [Primary]
GS1	01850062218313 [Package]; Contains: 00850062218314; Package: [100 Units]; In Commercial Distribution
GS1	08850062218316 [Unit of Use]

FDA Product Code

• FMF: Syringe, Piston

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: 2025-11-28
• Device Publish Date: 2025-11-20

On-Brand Devices [LMP]

• 01850062218313: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 01850062218306: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu