BBL™ CultureSwab™ 220115

GUDID 58053326002088

CultureSwab Sterile Single Swab

COPAN ITALIA SPA

General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use

• Primary Device ID: 58053326002088
• NIH Device Record Key: 460332fd-82a8-4d4a-bfe6-98f14c8a8d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BBL™ CultureSwab™
• Version Model Number: 220115
• Catalog Number: 220115
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• 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: 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
GS1	18053326002080 [Unit of Use]
GS1	38053326002084 [Primary]
GS1	58053326002088 [Package]; Contains: 38053326002084; Package: [6 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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [BBL™ CultureSwab™ ]

• 58053326002095: CultureSwab Sterile Double Swab
• 58053326002088: CultureSwab Sterile Single Swab
• 58053326002019: CultureSwab Cary-Blair Agar Single Swab
• 58053326002002: CultureSwab Stuart Flexible Wire
• 58053326001999: CultureSwab Stuart
• 58053326001982: CultureSwab Stuart Soft Wire
• 58053326001975: CultureSwab Liquid Stuart Single Swab
• 58053326001968: CultureSwab Amies Flexible Wire
• 58053326001951: CultureSwab Amies Soft Wire
• 58053326001944: CultureSwab Amies
• 58053326001937: CultureSwab Liquid Amies Single Swab
• 58053326001883: CultureSwab Liquid Stuart Double Swab
• 58053326001876: CultureSwab Liquid Amies Double Swab