O2-MAX
GUDID 10841470101289
PULMODYNE INC
Respiratory oxygen therapy system| Primary Device ID | 10841470101289 |
| NIH Device Record Key | 7080a070-f988-483c-805a-ee66ea81b9c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O2-MAX |
| Version Model Number | 313-7070-8 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841470101282 [Primary] |
| GS1 | 10841470101289 [Package] Contains: 00841470101282 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 | 2016-01-29 |
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 |
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