| Primary Device ID | 08906124941477 |
| NIH Device Record Key | 92ded2c2-829f-4343-b87f-26a044b9961c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TEKNA Manufacturing Pvt. Ltd. |
| Version Model Number | Hybrid 3200 series Monoplace Hyperbaric Chamber |
| Catalog Number | Hybrid 3200/40 Monoplace Hyperbaric Chamber |
| Company DUNS | 876896922 |
| Company Name | TEKNA MANUFACTURING PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08906124941477 [Primary] |
| CBF | Chamber, Hyperbaric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2024-09-03 |
| 08906124940005 | Modular Multiplace hyperbaric chamber consisting of ASME 'U' stamped pressure vessel that can ac |
| 08906124941477 | Hybrid 3200 Series Monoplace Hyperbaric Chamber consisting of ASME 'U' stamped pressure vessel t |
| 08906124943068 | Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can ac |
| 08906124943051 | Modular Multiplace Hyperbaric Chamber consisting of ASME 'U' Stamped pressure vessel that can ac |