| Primary Device ID | 10850014433922 |
| NIH Device Record Key | ea434a56-bc62-4b51-9767-5b52dc3221e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Non-rebreather mask |
| Version Model Number | 1 |
| Catalog Number | DU1060 |
| Company DUNS | 926603486 |
| Company Name | DISTRIBUTION UNLIMITED, LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014433925 [Primary] |
| GS1 | 10850014433922 [Package] Contains: 00850014433925 Package: Case [50 Units] In Commercial Distribution |
| KGB | Mask, Oxygen, Non-Rebreathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
| 10850014433137 - IV Extension Set 6" | 2020-08-27 are connected to IV catheters to allow a larger distance between the patient and the fluid being administered which is often nec |
| 20850014433646 - Universal Block Procedure Trays | 2020-08-27 include a wide selection of support materials and quality components needed to perform many pain management procedures. |
| 00850014433154 - Nasal Oxygen Cannula | 2020-08-21 The nasal cannula is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respira |
| 10850014433168 - Grounding Pads | 2020-08-21 A grounding pad is placed on the body (usually the thigh) before the surgery to protect the person from the harmful effects of t |
| 20850014433219 - ETCO2 Nasal Cannula | 2020-08-21 A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with |
| 10850014433236 - Sterile Specimen Cup with Temp Strip | 2020-08-21 The urine collection cup is a sterile plastic cup with a temperature strip and leak-resistant lid with a capacity of 90mL. This |
| 10850014433106 - Anesthesia Mask (Large) | 2020-08-14 are rubber or silicone masks that cover both the mouth and nose of the patient. |
| 10850014433120 - Anesthesia Mask (Medium) | 2020-08-14 are rubber or silicone masks that cover both the mouth and nose of the patient. |