| Primary Device ID | 04719872000013 |
| NIH Device Record Key | 14bab18c-88a9-433e-8219-c4bde3a8e06c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PAHI PAH-S1 Monoplace Hyperbaric Chamber |
| Version Model Number | PAH-S1 |
| Company DUNS | 658755160 |
| Company Name | PAN-AMERICA HYPERBARICS 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (972)4230377 |
| service@panamericahbo.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872000013 [Primary] |
| CBF | Chamber, Hyperbaric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-10 |
| Device Publish Date | 2016-08-24 |
| 04719872000006 - PAHI VersalVent | 2018-07-10 The VersalVent Model V1 Hyperbaric Chamber Ventilator is indicated for use with adult patients in respiratory failure or any oth |
| 04719872000013 - PAHI PAH-S1 Monoplace Hyperbaric Chamber | 2018-07-10The PAH-SI Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum operating pressure of |
| 04719872000013 - PAHI PAH-S1 Monoplace Hyperbaric Chamber | 2018-07-10 The PAH-SI Hyperbaric Chamber System is a Class B monoplace hyperbaric chamber designed to treat one patient at up to a maximum |