SnapshotNIR

GUDID B376KD2050

Tissue oxygenation imaging device

Kent Imaging Inc

Tissue saturation oximeter

• Primary Device ID: B376KD2050
• NIH Device Record Key: c6f8f05e-e34d-4851-8f3e-61dca07561ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SnapshotNIR
• Version Model Number: KD205
• Company DUNS: 246859016
• Company Name: Kent Imaging Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B376KD2050 [Primary]

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: 2024-04-15
• Device Publish Date: 2024-04-05

On-Brand Devices [SnapshotNIR]

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