| Primary Device ID | 00853512006769 |
| NIH Device Record Key | b0ae072a-79f6-4343-be8d-60898f0c4276 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIKOPrep |
| Version Model Number | 2121-5 |
| Catalog Number | 2121-5 |
| Company DUNS | 073648341 |
| Company Name | NIKOMED USA |
| Device Count | 5 |
| 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 | false |
| 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 |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853512006769 [Unit of Use] |
| GS1 | 10853512006766 [Primary] |
| DRX | Electrode, Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-27 |
| Device Publish Date | 2022-10-19 |
| 00853512006776 | Strips for Skin Preparation (Individual Pieces) |
| 00853512006769 | Strips for Skin Preparation (1 card of 5 pieces) |