| Primary Device ID | 20817522013388 |
| NIH Device Record Key | c8a38d0a-97c8-498b-a78d-318e010aee79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Swabeze |
| Version Model Number | KMI-111 |
| Catalog Number | KMI-111 |
| Company DUNS | 066175613 |
| Company Name | KENTEC MEDICAL, INC. |
| Device Count | 50 |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817522013384 [Primary] |
| GS1 | 10817522013381 [Unit of Use] |
| GS1 | 20817522013388 [Package] Contains: 00817522013384 Package: box [300 Units] In Commercial Distribution |
| GS1 | 30817522013385 [Package] Package: case [3600 Units] In Commercial Distribution |
| KXF | Applicator, Absorbent Tipped, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-05 |
| Device Publish Date | 2024-06-27 |
| 20817522013340 | low absorption foam swab |
| 20817522013388 | foam swab |
| 20817522013364 | foam swab |
| 20817522013357 | foam swab |
| 20817522013371 | foam swab |