SnapshotNIR

GUDID B376KD2040

Tissue oxygenation imaging device

Kent Imaging Inc

Tissue saturation oximeter

• Primary Device ID: B376KD2040
• NIH Device Record Key: a1d72e7e-af2d-4033-b8bd-70557e6764e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SnapshotNIR
• Version Model Number: KD204
• Company DUNS: 246859016
• Company Name: Kent Imaging 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B376KD2040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201976

FDA Product Code

• MUD: Oximeter, Tissue Saturation

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: 2020-12-25
• Device Publish Date: 2020-12-17

On-Brand Devices [SnapshotNIR]

• B376KD2040: Tissue oxygenation imaging device
• B376KD2050: Tissue oxygenation imaging device