Female NRFit Tip Cap 57-603

GUDID B212576032

Female NRFit Tip Cap for male Neuraxial devices

INTERNATIONAL MEDICAL INDUSTRIES INC.

NRFit-formatted protective cap

• Primary Device ID: B212576032
• NIH Device Record Key: cccd98eb-ac8f-422e-b771-14535ee782b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Female NRFit Tip Cap
• Version Model Number: 57-603
• Catalog Number: 57-603
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 10
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B212576030 [Unit of Use]
HIBCC	B212576031 [Primary]
HIBCC	B212576032 [Package]; Contains: B212576031; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201031

FDA Product Code

• QEH: Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

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: 2026-02-02
• Device Publish Date: 2026-01-23

Devices Manufactured by INTERNATIONAL MEDICAL INDUSTRIES INC.

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