O2-MAX
GUDID 10841470105034
PULMODYNE INC
Respiratory oxygen therapy system| Primary Device ID | 10841470105034 |
| NIH Device Record Key | 4084f34a-eb56-439b-8556-ed74b327866f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O2-MAX |
| Version Model Number | 313-8008XN-1 |
| Company DUNS | 030619483 |
| Company Name | PULMODYNE 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 317-246-5505 |
| info@pulmodyne.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841470105037 [Primary] |
| GS1 | 10841470105034 [Package] Contains: 00841470105037 Package: [10 Units] In Commercial Distribution |
FDA Product Code
| BYE | Attachment, Breathing, Positive End Expiratory Pressure |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-11 |
| Device Publish Date | 2016-06-24 |
On-Brand Devices [O2-MAX]
Trademark Results [O2-MAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 O2-MAX 90533721 not registered Live/Pending |
Engineered Medical Systems, Inc. 2021-02-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.