| Primary Device ID | 10853292007533 |
| NIH Device Record Key | d0196cc0-acc4-4471-a602-2ffe06ae8888 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nebu-Life |
| Version Model Number | RTG-07106 |
| Catalog Number | RTG-07106 |
| Company DUNS | 080216804 |
| Company Name | CUTTING EDGE HC BRANDS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9999999999 |
| info@rtghealth.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853292007536 [Primary] |
| GS1 | 10853292007533 [Package] Contains: 00853292007536 Package: Carton [50 Units] In Commercial Distribution |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-11 |
| Device Publish Date | 2019-02-25 |
| 10853292007533 | Nebu-Life Hand Held Nebulizer 6cc Cup, w/ Pediatric Aerosol Elongated Mask & 7' Tube (2.1m). P |
| 10853292007526 | Nebu-Life Hand Held Nebulizer 6cc Cup, w/Adult Aerosol Elongated Mask & 7' Tube (2.1m). ADULT. |
| 10853292007519 | Nebu-Life Hand Held Nebulizer Kit 6cc Cup, T Adaptor, Mouthpiece, 7' (2.1m) Tubing, 6" Flextube |
| 10853292007502 | Nebu-Life Hand Held Nebulizer Kit 6cc Cup, T Adaptor, Mouthpiece, 7' (2.1m) Tubing, 6" Flextube |
| 10853292007496 | Nebu-Life Hand Held Nebulizer 6cc Cup, w/7' Tube (2.1m), Mouthpiece & T-Adaptor. The Jet Nebuli |
| 10853292007489 | Nebu-Life Hand Held Nebulizer 6cc Cup, w/7' Tube (2.1m). The Jet Nebulizer Bottle Set is used t |
| 10853292007472 | Nebu-Life Hand Held Nebulizer 6cc Cup. The Jet Nebulizer Bottle Set is used to administer variou |