Oral Tamper Evident Cap ISOTEC-OR

GUDID B212ISOTECOR2

Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Evidence of Access and Positive Closure

INTERNATIONAL MEDICAL INDUSTRIES INC.

Oral liquid dose dispenser

• Primary Device ID: B212ISOTECOR2
• NIH Device Record Key: e01345d7-ca9d-4a49-b9b8-61bd1c4260dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral Tamper Evident Cap
• Version Model Number: ISOTEC-OR
• Catalog Number: ISOTEC-OR
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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	B212ISOTECOR0 [Unit of Use]
HIBCC	B212ISOTECOR1 [Primary]
HIBCC	B212ISOTECOR2 [Package]; Contains: B212ISOTECOR1; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• KYX: Dispenser, Liquid Medication

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: 2018-03-29
• Device Publish Date: 2016-10-14

On-Brand Devices [Oral Tamper Evident Cap]

• B212ISOTECOR2: Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1
• B21273211: Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1
• B21257752: Oral Tamper Evident Cap for NeoMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provide
• B21257742: Oral Tamper Evident Cap for Comar Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides
• B21257732: Oral Tamper Evident Cap for BD Oral Dispenser. Non-Sterile, Bag of 100, Box of 1000. Provides Ev
• B2125770IMI2: Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1
• B212172862: Oral Tamper Evident Cap for Baxter / ExactaMed Oral Dispenser. Non-Sterile, Bag of 100, Box of 1
• B2125773100RFID2: RFID OTEC – 100 units/bag, 1 bag/carton
• B2125770100RFID2: RFID OTEC – 100 units/bag, 1 bag/carton