| Primary Device ID | B376KB100D0 |
| NIH Device Record Key | 3aac06f1-2838-4748-98a8-d6636697e863 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drape KB100 Series |
| Version Model Number | KB100D |
| Company DUNS | 246859016 |
| Company Name | Kent Imaging Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B376KB100D0 [Primary] |
| HIBCC | B376KB100D1 [Package] Package: Case [20 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-18 |
| Device Publish Date | 2025-07-10 |
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| B376KD2050 - SnapshotNIR | 2024-04-15 Tissue oxygenation imaging device |
| B376KD2040 - SnapshotNIR | 2020-12-25 Tissue oxygenation imaging device |