VascuChek Kit VC-KIT-02

GUDID 00813079022688

Kit that contains 1 tranceiver, 1 clinical probe, 1 speaker Dock, and 1 pack of ultrasound gel

REMINGTON MEDICAL, INC.

Laser Doppler blood flowmeter
Primary Device ID00813079022688
NIH Device Record Keycf64537e-3fd3-4acf-acef-2d8929b1b05a
Commercial Distribution StatusIn Commercial Distribution
Brand NameVascuChek Kit
Version Model NumberVC-KIT-02
Catalog NumberVC-KIT-02
Company DUNS788472314
Company NameREMINGTON MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+017708888520
Emailregulatory@remmed.com
Phone+017708888520
Emailregulatory@remmed.com
Phone+017708888520
Emailregulatory@remmed.com
Phone+017708888520
Emailregulatory@remmed.com
Phone+017708888520
Emailregulatory@remmed.com
Phone+017708888520
Emailregulatory@remmed.com
Phone+017708888520
Emailregulatory@remmed.com

Device Dimensions

Length290.8 Millimeter
Length290.8 Millimeter
Length290.8 Millimeter
Length290.8 Millimeter
Length290.8 Millimeter
Length290.8 Millimeter
Length290.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100813079022688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPWFLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-05
Device Publish Date2025-11-27

On-Brand Devices [VascuChek Kit]

00813079022640Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel
00813079022688Kit that contains 1 tranceiver, 1 clinical probe, 1 speaker Dock, and 1 pack of ultrasound gel

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