| Primary Device ID | 00852834007065 |
| NIH Device Record Key | f2867bbd-c2b0-46c7-88d3-3946c519d344 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Newtowne Hyperbarics |
| Version Model Number | WI |
| Company DUNS | 361527229 |
| Company Name | TYPHOON WATER WARES LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 | 410-575-4220 |
| sales@newtownehyperbarics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852834007065 [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 | 2020-03-23 |
| Device Publish Date | 2020-03-13 |
| 00865439000270 | Seal 27" mild hyperbaric chamber |
| 00865439000263 | Class 7 portable hyperbaric chamber. |
| 00865439000256 | Seal model, 38" diameter, portable hyperbaric chamber. |
| 00865439000249 | Seal model, 31" diameter, portable hyperbaric chamber. |
| 00865439000232 | Seal model, 24" diameter, portable hyperbaric chamber. |
| 00865439000225 | Class 4 model, 38" diameter, portable hyperbaric chamber. |
| 00865439000218 | Class 4 model, 31" diameter, portable hyperbaric chamber. |
| 00865439000201 | Class 4 model, 24" diameter, portable hyperbaric chamber. |
| 00852834007058 | Seal 40" mild hyperbaric chamber |
| 00852834007041 | Seal 34" mild hyperbaric chamber |
| 00852834007034 | Class 4-40" mild hyperbaric chamber |
| 00852834007027 | Class 4-34" mild hyperbaric chamber |
| 00852834007010 | Class 4-27" mild hyperbaric chamber |
| 00852834007065 | Newtowne Hyperbarics Walk In Chamber: 54" Dia x 81" L |