VascuChek Surgical Probe VC-SP-01

GUDID 10813079022616

Surgical Probe (sterile) used with transceiver

REMINGTON MEDICAL, INC.

Laser Doppler blood flowmeter

• Primary Device ID: 10813079022616
• NIH Device Record Key: 46e62fa1-75dc-4ce8-999e-163c2c75669c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VascuChek Surgical Probe
• Version Model Number: VC-SP-01
• Catalog Number: VC-SP-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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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
• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com
• Phone: +017708888520
• Email: regulatory@remmed.com

Device Dimensions

• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter
• Length: 65.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079022619 [Primary]
GS1	10813079022616 [Package]; Contains: 00813079022619; Package: Inner Carton [10 Units]; In Commercial Distribution

FDA Product Code

• DPW: FLOWMETER, BLOOD, CARDIOVASCULAR

Sterilization

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

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

[10813079022616]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-02
• Device Publish Date: 2024-08-23

Devices Manufactured by REMINGTON MEDICAL, INC.

• 10813079022616 - VascuChek Surgical Probe: 2024-09-02Surgical Probe (sterile) used with transceiver
• 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.
• 10813079020223 - Bone Marrow "I" Needle: 2020-10-02 15ga (1.8mm) x 1 7/8" (5cm)
• 20813079020237 - Bone Marrow "I" Needle: 2020-10-02 16ga (1.7mm) x 1 7/8" (5cm)
• 10813079020247 - Bone Marrow "J" Needle Double Diamond Tip: 2020-10-02 11ga (3.0mm) x 4in. (10cm)