Oracol+

GUDID 05060166524531

MALVERN MEDICAL DEVELOPMENTS LIMITED

Oral/upper respiratory tract specimen collection kit

• Primary Device ID: 05060166524531
• NIH Device Record Key: 1d28e8b0-89da-4085-b7a8-7dce26e058bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oracol+
• Version Model Number: S14
• Company DUNS: 235059214
• Company Name: MALVERN MEDICAL DEVELOPMENTS LIMITED
• Device Count: 1
• 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: 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	05060166524326 [Primary]
GS1	05060166524531 [Package]; Contains: 05060166524326; Package: Box [500 Units]; In Commercial Distribution

FDA Product Code

• KXG: Applicator, Absorbent Tipped, Sterile

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: 2024-12-27
• Device Publish Date: 2024-12-19

Devices Manufactured by MALVERN MEDICAL DEVELOPMENTS LIMITED

• 05060166524524 - Oracol: 2024-12-27
• 05060166525743 - Oracol Swab: 2024-12-27
• 05060166524531 - Oracol+: 2024-12-27
• 05060166524531 - Oracol+: 2024-12-27