EZflow MAX
GUDID 30641043320031
MERCURY ENTERPRISES, INC.
Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated| Primary Device ID | 30641043320031 |
| NIH Device Record Key | a6b5df7f-1543-4957-80ec-894859bc6ee3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZflow MAX |
| Version Model Number | 10-32003 |
| Company DUNS | 032705659 |
| Company Name | MERCURY ENTERPRISES, INC. |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10641043320037 [Primary] |
| GS1 | 30641043320031 [Package] Contains: 10641043320037 Package: [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993558
FDA Product Code
| CAF | Nebulizer (Direct Patient Interface) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-07-31 |
| Device Publish Date | 2016-03-09 |
On-Brand Devices [EZflow MAX]
| 30641043320093 | 10-32009 |
| 30641043320048 | 10-32004 |
| 30641043320031 | 10-32003 |
Trademark Results [EZflow MAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZFLOW MAX 76473511 2773473 Live/Registered |
MERCURY ENTERPRISES, INC. 2002-12-09 |
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