NeoConnect Tamper Evident Cap Enfit Syringe Compat PNS-TENC

GUDID B212PNSTENC2

Tamper Evident Cap for use with ENFit Syringes, Purple. Non-sterile. Bag of 100. Package of 1000. Provides positive closure and tamper evidence.

INTERNATIONAL MEDICAL INDUSTRIES INC.

Syringe tip cap

• Primary Device ID: B212PNSTENC2
• NIH Device Record Key: 27d0ae2a-5d27-4045-b27a-e04d5e9cb049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoConnect Tamper Evident Cap Enfit Syringe Compat
• Version Model Number: PNS-TENC
• Catalog Number: PNS-TENC
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES 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: false
• 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	B212PNSTENC0 [Unit of Use]
HIBCC	B212PNSTENC1 [Primary]
HIBCC	B212PNSTENC2 [Package]; Contains: B212PNSTENC1; Package: Box [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170672

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-26

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