VascuChek Speaker Dock VC-SD-01

GUDID 00813079022671

Speaker Dock is connected to Transciever via bluetooth

REMINGTON MEDICAL, INC.

Laser Doppler blood flowmeter

• Primary Device ID: 00813079022671
• NIH Device Record Key: bae6b307-78b9-438f-ab8c-f6b957778e81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VascuChek Speaker Dock
• Version Model Number: VC-SD-01
• Catalog Number: VC-SD-01
• Company DUNS: 788472314
• Company Name: REMINGTON MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Customer Support Contacts

• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com

Device Dimensions

• Length: 136 Millimeter
• Length: 136 Millimeter
• Length: 136 Millimeter
• Length: 136 Millimeter
• Length: 136 Millimeter
• Length: 136 Millimeter
• Length: 136 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079022671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251904

FDA Product Code

• DPW: FLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-05
• Device Publish Date: 2025-11-27

Devices Manufactured by REMINGTON MEDICAL, INC.

• 00813079022664 - VascuChek Transceiver: 2025-12-05 Hand-held, battery operated transciever used to monitor blood flow.
• 00813079022671 - VascuChek Speaker Dock: 2025-12-05Speaker Dock is connected to Transciever via bluetooth
• 00813079022671 - VascuChek Speaker Dock: 2025-12-05 Speaker Dock is connected to Transciever via bluetooth
• 00813079022688 - VascuChek Kit: 2025-12-05 Kit that contains 1 tranceiver, 1 clinical probe, 1 speaker Dock, and 1 pack of ultrasound gel
• 10813079022616 - VascuChek Surgical Probe: 2024-09-02 Surgical Probe (sterile) used with transceiver
• 00813079022626 - VascuChek Transceiver: 2024-09-02 Hand-held, battery operated transceiver used to monitor blood flow.
• 00813079022633 - VascuChek Charger: 2024-09-02 Replacement Charger used with the transceiver
• 00813079022640 - VascuChek Kit: 2024-09-02 Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel
• 10813079022654 - VascuChek Clinical Probe: 2024-09-02 Clinical Probe (non-sterile) used with transceiver.