VascuChek Kit VC-Kit-01

GUDID 00813079022640

Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel

REMINGTON MEDICAL, INC.

Laser Doppler blood flowmeter
Primary Device ID00813079022640
NIH Device Record Key75b3bd77-835d-4a50-84d2-f22d8fca54f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVascuChek Kit
Version Model NumberVC-KIT-01
Catalog NumberVC-Kit-01
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
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
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
Length290.8 Millimeter
Length290.8 Millimeter
Length290.8 Millimeter
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
GS100813079022640 [Primary]

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 Date2024-09-02
Device Publish Date2024-08-23

Devices Manufactured by REMINGTON MEDICAL, INC.

10813079022616 - VascuChek Surgical Probe2024-09-02 Surgical Probe (sterile) used with transceiver
00813079022626 - VascuChek Transceiver2024-09-02 Hand-held, battery operated transceiver used to monitor blood flow.
00813079022633 - VascuChek Charger2024-09-02 Replacement Charger used with the transceiver
00813079022640 - VascuChek Kit2024-09-02Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel
00813079022640 - VascuChek Kit2024-09-02 Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel
10813079022654 - VascuChek Clinical Probe2024-09-02 Clinical Probe (non-sterile) used with transceiver.
10813079020223 - Bone Marrow "I" Needle2020-10-02 15ga (1.8mm) x 1 7/8" (5cm)
20813079020237 - Bone Marrow "I" Needle2020-10-02 16ga (1.7mm) x 1 7/8" (5cm)
10813079020247 - Bone Marrow "J" Needle Double Diamond Tip2020-10-02 11ga (3.0mm) x 4in. (10cm)

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