DEVICE: Sherlock 3CG+, BD SiteRite 9 Ultrasound System (00801741231124)
Device Identifier (DI) Information
Sherlock 3CG+, BD SiteRite 9 Ultrasound System
SR9v1.1.0
In Commercial Distribution
SR9v1.1.0
Bard Access Systems, Inc.
SR9v1.1.0
In Commercial Distribution
SR9v1.1.0
Bard Access Systems, Inc.
Site~Rite 9 Ultrasound Software
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61667 | Central venous catheter navigation system, electrocardiographic/magnetic |
An assembly of devices intended to use electrocardiographic (ECG) and magnetic data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC)]. It includes a mains electricity (AC-powered) control unit [with internal rechargeable batteries] and visual display, ECG skin electrodes, lead(s) and cable(s), a magnetic sensor to be placed on the patient’s chest, and a remote control. The system is designed to be used with a dedicated catheter/stylet (not included) which functions as an intravascular ECG electrode and magnet whose position is detected by the sensor.
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Active | false |
40761 | General-purpose ultrasound imaging system |
A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LLZ | System, image processing, radiological |
ITX | Transducer, ultrasonic, diagnostic |
LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days |
IYO | System, imaging, pulsed echo, ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
35f24755-8dcd-40b8-8b57-415bb2a738ba
March 27, 2024
1
March 19, 2024
March 27, 2024
1
March 19, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-0890
medical.services@crbard.com
medical.services@crbard.com