O2-MAX
GUDID 10841470100404
PULMODYNE INC
Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system Respiratory oxygen therapy system| Primary Device ID | 10841470100404 |
| NIH Device Record Key | a6d4f531-3248-4cc2-a8cd-126d701c99cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O2-MAX |
| Version Model Number | 313-7555XNF |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841470100407 [Primary] |
| GS1 | 10841470100404 [Package] Contains: 00841470100407 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-24 |
| Device Publish Date | 2020-12-16 |
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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