| Primary Device ID | 00850002860245 |
| NIH Device Record Key | d2ad51a3-e9b9-4afa-8045-359ff715e922 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clever Choice Ultrasonic Humidifier |
| Version Model Number | CCH-400 |
| Catalog Number | 50002-0860-24 |
| Company DUNS | 116722847 |
| Company Name | S.D.I. USA, INC. |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1.877.342.2385 |
| customersupport@simplediagnostics.com |
| Total Volume | 400 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002860245 [Primary] |
| GS1 | 10850002860242 [Package] Package: Case [12 Units] In Commercial Distribution |
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-18 |
| Device Publish Date | 2019-11-08 |
| 10850002860709 - Comfort EZ Pro | 2023-08-09 Safety Insulin Pen Needles - 30G 8mm 100 count |
| 10850002860716 - Comfort EZ Pro | 2023-08-09 Safety Insulin Pen Needles - 31G 5mm 100 count |
| 10850002860723 - Comfort EZ Pro | 2023-08-09 Safety Insulin Pen Needles - 31G 4mm 100 count |
| 00850002860481 - Clever Choice | 2022-04-12 Clever Choice Universal Fit Reusable Nebulizer Kit Adult Size Contains Nebulizer Mask with elastic strap, Nebulizer Cup, 5 x Fil |
| 10850002860495 - Clever Choice | 2022-04-12 Clever Choice Universal Fit Reusable Nebulizer Kit - Child Size Contains Nebulizer Mask with elastic strap, Nebulizer Cup, 5 x F |
| 00850002860375 - Clever Choice Comfort Protect | 2020-03-05 Clever Choice Comfort Protect Adult Underpads - 30" x 36" 150 pack |
| 00850002860429 - Clever Choice Comfort Protect | 2020-03-05 Clever Choice Comfort Protect Adult Underpads 30" x 36" 25 Pack |
| 00850002860245 - Clever Choice Ultrasonic Humidifier | 2019-11-18Clever Choice Ultrasonic Humidifier. 400ml / 13.5oz tank size. Measuring cup included. Timer function and low water auto-shutoff. |
| 00850002860245 - Clever Choice Ultrasonic Humidifier | 2019-11-18 Clever Choice Ultrasonic Humidifier. 400ml / 13.5oz tank size. Measuring cup included. Timer function and low water auto-shutoff |