VascuChek Transceiver VC-TRX-02

GUDID 00813079022664

Hand-held, battery operated transciever used to monitor blood flow.

REMINGTON MEDICAL, INC.

Laser Doppler blood flowmeter

• Primary Device ID: 00813079022664
• NIH Device Record Key: 7119a311-6685-4f7e-9274-e9ac98cf7721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VascuChek Transceiver
• Version Model Number: VC-TRX-02
• Catalog Number: VC-TRX-02
• 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: 62.2 Millimeter
• Length: 62.2 Millimeter
• Length: 62.2 Millimeter
• Length: 62.2 Millimeter
• Length: 62.2 Millimeter
• Length: 62.2 Millimeter
• Length: 62.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079022664 [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

On-Brand Devices [VascuChek Transceiver]

• 00813079022626: Hand-held, battery operated transceiver used to monitor blood flow.
• 00813079022664: Hand-held, battery operated transciever used to monitor blood flow.