| Primary Device ID | 00812594013430 |
| NIH Device Record Key | b47ef9a9-dac0-44bb-b2f7-93ff0dc7a5bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeoSmile Hydrogel |
| Version Model Number | 10812594013437 |
| Catalog Number | N7321 |
| Company DUNS | 198013435 |
| Company Name | Neotech Products LLC |
| Device Count | 75 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812594013430 [Unit of Use] |
| GS1 | 10812594013437 [Primary] |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-15 |
| Device Publish Date | 2023-09-07 |
| 10812594013239 - NeoSnug Micro | 2024-10-22 NeoSnug is intended to support, secure, and hold gastrointestinal tubes on patients’ skin. 30 per box - 15 sets of 2 (left & R |
| 10812594013246 - NeoSnug Oral - Small | 2024-10-22 NeoSnug is intended to support, secure, and hold gastrointestinal tubes on patients’ skin. 40 pieces |
| 00812594012082 - NeoLead® | 2023-11-07 NeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph elec |
| 00812594011467 - EZ Care Softouch Large - Black | 2023-09-18 Trach Holder 18" - Tan |
| 10812594012928 - NeoSnug | 2023-09-18 Tubing Holder - Unique shape ideal for securing tubes close to the nares - 15 sets of 2 (Left/Right) |
| 00812594013430 - NeoSmile Hydrogel | 2023-09-15Hydrogel Temp Probe 75pcs / Box |
| 00812594013430 - NeoSmile Hydrogel | 2023-09-15 Hydrogel Temp Probe 75pcs / Box |
| 00812594013478 - Neotech Bridge - Kit | 2023-06-14 Breastfeeding Assistance Device - Kit |
| 00812594012600 - Neotech Bridge (30 pcs) | 2023-06-14 Breastfeeding Assistance Device (30 pcs per Box) |