Biim Ultrasound L12-4 Linear Array Transducer P001000

GUDID 07090045490006

Biim Ultrasound L12-4 Linear Array Transducer

Biim Ultrasound AS

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 07090045490006
• NIH Device Record Key: f765f6da-d8fe-49ac-b65a-f967d0b58b4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biim Ultrasound L12-4 Linear Array Transducer
• Version Model Number: P001000
• Catalog Number: P001000
• Company DUNS: 671316618
• Company Name: Biim Ultrasound AS
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	07090045490006 [Primary]
GS1	07090045490082 [Package]; Package: BX [1 Units]; In Commercial Distribution
GS1	07090045490167 [Package]; Package: BX [1 Units]; In Commercial Distribution
GS1	07090045490280 [Package]; Package: EA [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173138

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-01-17
• Device Publish Date: 2018-01-26

Devices Manufactured by Biim Ultrasound AS

• 07090045490365 - Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0): 2019-10-29 Biim Ultrasound L12-4 Linear Array Transducer (Version P2.0)
• 07090045490327 - Biim iOS App, P2.0: 2019-10-02 Biim iOS App, P2.0
• 07090045490334 - Biim Android App, P2.0: 2019-10-02 Biim Android App, P2.0
• 07090045490358 - Battery Charger AU, Biim Ultrasound: 2019-10-02 Battery Charger AU, Biim Ultrasound
• 07090045490266 - Battery Charger EU, Biim Ultrasound: 2019-02-11 Battery Charger EU, Biim Ultrasound
• 07090045490242 - Battery Charger UK, Biim Ultrasound: 2019-02-11 Battery Charger UK, Biim Ultrasound
• 07090045490303 - Biim iOS App, P1.3.2: 2019-02-11 Biim iOS App, P1.3.2
• 07090045490310 - Biim Android App, P1.3.2: 2019-02-11 Biim Android App, P1.3.2